Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03812679
• Collaborator: (none)
• Enrollment: 22
• Locations: 11
• Arm: 1
• Actual Duration (Months): 14
• Patients Per Site: 2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Peritoneal dialysis (PD) is a well-established treatment for renal failure including long-term management of end stage renal disease (ESRD) by continuous ambulatory peritoneal dialysis or automated peritoneal dialysis (APD).

Complementary therapies offer longer term survival for patients with ESRD. However, none of them are devoid of side effects and today their limitations are better understood by the nephrologist.

The AMIA APD Solution Generation System combines an updated AMIA APD Cycler with Sharesource Platform (previously cleared) with an in-home water system technology and leverages newly developed AMIA APD Concentrates.

The AMIA APD Concentrates, after dilution by the AMIA APD Solution Generation System, are indicated for adult patients in acute or chronic renal failure when non-dialytic medical therapy is judged to be inadequate.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease (ESRD)	Device: AMIA APD Solution Generation System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Performance Evaluation of the AMIA Automated Peritoneal Dialysis (APD) Solution Generation System in Patients Using the AMIA APD Cycler
• Actual Study Start Date: Dec 20, 2018
• Actual Primary Completion Date: Feb 19, 2020
• Actual Study Completion Date: Feb 19, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: AMIA APD Solution Generation System A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit.

Device: AMIA APD Solution Generation System; The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).

Outcome Measures

Primary Outcome Measures

1. Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit [Week 1, 4, 8 and 12]

   The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.

2. Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit [Week 1, 4, 8 and 12]

   Microbiological testing within <=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and <0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP <61> and USP <85> and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.

3. Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit [Week 1, 4, 8 and 12]

   Microbiological testing within <=0 CFU/mL limit for TAMC and TYMC and <0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP <71> and USP <85>.

Secondary Outcome Measures

1. Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8 [Baseline, Week 5 or Week 6 or Week 7 or Week 8]

   Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient is 18 years or older.

2. Patient with ESRD receiving PD therapy, and who is already trained and regularly using the AMIA or HomeChoice APD Cycler with Dianeal PD Solution for at least 12 weeks.

3. Patient is receiving or willing and able to use Dianeal Low Calcium (2.5 mEq/L) PD prescriptive regimen at study treatment initiation per Investigator's assessment.

4. Patient demonstrates adequate PD therapy with clinical euvolemia as assessed by the Investigator with a total Kt/Vurea of a minimum of 1.7 within 45 days of Screening, or measured at Screening. If a total Kt/Vurea is not available within 45 days of Screening, it will be measured at Screening.

5. Investigator assesses that, with appropriate training, the patient will be able to successfully manage his/her dialysis treatments with the AMIA APD Solution Generation System.

6. Patient is available and is willing to complete training on the AMIA APD Solution Generation System.

7. Patient and home environment are deemed suitable for treatment with the AMIA APD Solution Generation System, while in the home.

8. Home electrical and water assessments meet suitability criteria for the AMIA APD Solution Generation System.

9. The patient's home has suitable wireless connection or patient is willing to allow installation of suitable wireless connection.

10. Patient and/or care partner (if participating) is able to read and understand English, and provide informed consent after an explanation of the proposed study. If the patient does not read and understand English, patient may still participate if he/she has a co-residing care partner who reads and understands English, assessed as adequate by the PI.

11. Women of childbearing potential (not menopausal or surgically sterile) must not be pregnant. Serum qualitative and quantitative pregnancy test will be done within 14 days prior to initiation of study product.

• If qualitative serum β-hCG results are positive, repeat quantitative serum pregnancy test in 48 hours.

• If quantitative serum β-hCG levels show clinically significant rise within 48 hours, serum progesterone level should be taken. Serum progesterone > 5 ng/mL will exclude a patient from the study.

1. Sexually active males and females agree to use a reliable means of contraception during the study and for 30 days afterwards (e.g., oral contraceptive and condom, intrauterine device and condom, or diaphragm with spermicide and condom).

Exclusion Criteria:

1. Patient with a history of PD catheter dysfunction within 12 weeks prior to study enrollment, as evaluated by the Investigator.

2. Patient who had episodes of peritonitis or exit site infection within 12 weeks prior to study enrollment.

3. Patient who has signs of impending or current infection including a cloudy dialysis effluent or dialysis white cell count > 100/ μL or > 0.1 x 109/ L (after a dwell time of at least 2 hours), with > 50% polymorphonuclear cells, and/or positive dialysis effluent culture.

4. Patient who has a severe primary immune deficiency or other condition that may mask clinical signs of peritonitis, as evaluated by the Investigator.

5. Patient with a history of repeated non-compliance with PD, therapy (e.g., a substantial number of missed clinic visits, missed treatments or a history of mismanagement of diet or medications), as evaluated by the Investigator.

6. Patient who has acute renal failure with the chance for recovery.

7. Patient who is pre-scheduled for a living donor kidney transplant within the next 6 months.

8. Patient who is not expected to live at least 6 months while maintaining PD treatment.

9. Patient who had major abdominal surgery within 6 months prior to study enrollment.

10. Patient with current abdominal hernia, as evaluated by the Investigator.

11. Patient with advanced liver or pulmonary disease, as evaluated by the Investigator.

12. Positive serology test for Hepatitis B Virus or Hepatitis C Virus infection, or aspartate transaminase or alanine aminotransferase > 3 x upper limit of normal at Screening.

13. Patient with diagnosed stage III or IV New York Heart Association (NYHA) heart failure.

14. Patient who has an active malignancy.

15. History of a clinically significant illness and/or clinically significant surgery within the past 14 days preceding the Screening Visit as determined by the Investigator.

16. Patient who is enrolled in another interventional clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baxter Investigational Site	Jonesboro	Arkansas	United States	72401
2	Baxter Investigational Site	San Jose	California	United States	95125
3	Baxter Investigational Site	Jacksonville	Florida	United States	32224
4	Baxter Investigational Site	Chicago	Illinois	United States	60612
5	Baxter Investigational Site	Ann Arbor	Michigan	United States	48104
6	Baxter Investigational Site	Jackson	Mississippi	United States	39213
7	Baxter Investigational Site	New York	New York	United States	10021
8	Baxter Investigational Site	New York	New York	United States	10029
9	Baxter Investigational Site	Cleveland	Ohio	United States	44106
10	Baxter Investigational Site	Temple	Texas	United States	76508
11	Baxter Investigational Site	Fitchburg	Wisconsin	United States	53713

Sponsors and Collaborators

• Baxter Healthcare Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 1, 2019
• Statistical Analysis Plan - Mar 4, 2020

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT03812679
• Other Study ID Numbers: BXU011787
• First Posted: Jan 23, 2019
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Period Title: Overall Study
STARTED	22
COMPLETED	14
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.9 (13.67)
Sex: Female, Male (Count of Participants)
Female	14 63.6%
Male	8 36.4%
Race/Ethnicity, Customized (Count of Participants)
Asian	5 22.7%
Black or African American	7 31.8%
White	9 40.9%
Other	1 4.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit
Description	The dialysis solution generated by the simulated treatment will be sampled from the heater bag, compared to the specifications of Baxter's approved low calcium Dianeal PD solution. The following 9 test methods will be analyzed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
Time Frame	Week 1, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Measure Participants	22
Measure Tests	71
Week 1 (1.5% Dextrose): Met Specifications	91.3
Week 1 (1.5% Dextrose): Did Not Meet Specifications	0
Week 1 (1.5% Dextrose): Missing Results	8.7
Week 4 (2.5% Dextrose): Met Specifications	95
Week 4 (2.5% Dextrose): Did Not Meet Specifications	0
Week 4 (2.5% Dextrose): Missing Results	5
Week 8 (4.25% Dextrose): Met Specifications	85.7
Week 8 (4.25% Dextrose): Did Not Meet Specifications	0
Week 8 (4.25% Dextrose):Missing Results	14.3
Week 12 (1.5% Dextrose): Met Specifications	85.7
Week 12 (1.5% Dextrose): Did Not Meet Specifications	0
Week 12 (1.5% Dextrose): Missing Results	14.3

2. Primary Outcome

Title	Percentage of Tests Meeting Specifications for the Microbiological and Chemical Testing of Product Water From Water Device (Pre-sterilizing Filters) by Visit
Description	Microbiological testing within <=0 CFU/mL limit for total aerobic microbial count (TAMC) and total yeast/mold count (TYMC) and <0.03 EU/mL limit for Endotoxins, and chemical parameters. Product water from the WD (pre-sterilizing filters) was collected and tested for microbiological (including endotoxin) contamination per USP <61> and USP <85> and chemical contaminants according to ISO 13959. Chemical parameters include aluminum, copper, fluoride, lead, nitrate, sulphate, zinc, calcium, magnesium, potassium, sodium, antimony, arsenic, barium, beryllium, cadmium, chromium, mercury, selenium, silver, thallium, nickel, cobalt, total chlorine. Chemical measurements were collected using instruments such as meters, chromatography, etc. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications.
Time Frame	Week 1, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Measure Participants	22
Measure Tests	72
Week 1(Visit 1): Met Specifications	37.5
Week 1(Visit 1): Did Not Meet Specifications	0
Week 1(Visit 1): Missing Results	62.5
Week 4 (Visit 2): Met Specifications	60
Week 4 (Visit 2): Did Not Meet Specifications	15
Week 4 (Visit 2): Missing Results	25
Week 8 (Visit 3): Met Specifications	78.6
Week 8 (Visit 3): Did Not Meet Specifications	7.1
Week 8 (Visit 3): Missing Results	14.3
Week 12 (Visit 4): Met Specifications	64.3
Week 12 (Visit 4): Did Not Meet Specifications	14.3
Week 12 (Visit 4): Missing Results	21.4

3. Primary Outcome

Title	Percentage of Tests Meeting Specifications for the Microbiological Testing of Product Water From Holding Bag (Post-sterilizing Filters) by Visit
Description	Microbiological testing within <=0 CFU/mL limit for TAMC and TYMC and <0.03 EU/mL limit for Endotoxins. Data will be reported showing percentage of participants meeting specifications versus percentage of participants not meeting specification. If any one of the values falls outside the limits, then the particular test is considered NOT meeting specifications. A test was considered as meeting specifications if all of the following parameters fell within the specified limits: tryptic soy broth growth, fluid thioglycolate growth, and endotoxins. Water in the holding bag was collected and tested for microbiological contamination and endotoxin levels per USP <71> and USP <85>.
Time Frame	Week 1, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Measure Participants	22
Measure Tests	71
Week 1 (Visit 1): Met Specifications	100
Week 1 (Visit 1): Did Not Meet Specifications	0
Week 1 (Visit 1): Missing Results	0
Week 4 (Visit 2): Met Specifications	100
Week 4 (Visit 2): Did Not Meet Specifications	0
Week 4 (Visit 2): Missing Results	0
Week 8 (Visit 3): Met Specifications	92.9
Week 8 (Visit 3): Did Not Meet Specifications	0
Week 8 (Visit 3): Missing Results	7.1
Week 12 (Visit 4): Met Specifications	85.7
Week 12 (Visit 4): Did Not Meet Specifications	0
Week 12 (Visit 4): Missing Results	14.3

4. Secondary Outcome

Title	Change From Baseline in Total Kt/Vurea at Week 5, 6, 7, or 8
Description	Peritoneal dialysis adequacy will be measured by sample collection and calculation of Total Kt/Vurea. Weekly peritoneal Kt/Vurea was calculated from blood and 24-hour PD effluent samples and renal Kt/Vurea was calculated from 24-hour collection of urine samples (if applicable) and blood samples after the patient had been dialyzing with the AMIA APD Solution Generation System for at least 4 weeks. Total Kt/Vurea is the sum of peritoneal Kt/Vurea and renal Kt/Vurea. Note: This secondary efficacy endpoint was measured by sample collection and calculation of total Kt/Vurea, occurring one time during Week 5, 6, 7, or 8 of the Study Treatment Period.
Time Frame	Baseline, Week 5 or Week 6 or Week 7 or Week 8

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
Measure Participants	15
Mean (Standard Deviation) [Kt/Vurea]	-0.15 (0.370)

Adverse Events

Time Frame	AEs and SAEs will be collected after the informed consent is signed and will continue to be collected throughout the Study Treatment Period and during the follow-up period of 5 days after the last study treatment.
Arm/Group Title	AMIA APD Solution Generation System
Arm/Group Description	A simulated treatment will take place before the patient receives study treatment, during week 1 and after 4, 8 and 12 weeks of study treatment period. The dialysis solution generated by the simulated treatment will be collected from the system in the heater bag and used to evaluate the chemical composition of the final dialysis solution produced by patients using the AMIA APD Solution Generation System. Also, product water from the Water Device (pre-sterilizing filters) will be collected and tested at each visit. AMIA APD Solution Generation System: The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
All Cause Mortality
	AMIA APD Solution Generation System
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Serious Adverse Events
	AMIA APD Solution Generation System
	Affected / at Risk (%)	# Events
Total	3/22 (13.6%)
Cardiac disorders
Atrial fibrillation	1/22 (4.5%)	1
Infections and infestations
Peritonitis	1/22 (4.5%)	1
Peritonitis bacterial	1/22 (4.5%)	1
Other (Not Including Serious) Adverse Events
	AMIA APD Solution Generation System
	Affected / at Risk (%)	# Events
Total	2/22 (9.1%)
Vascular disorders
Hypotension	2/22 (9.1%)	2

Limitations/Caveats

The study was terminated for business reasons not due to scientific data. Sufficient data was acquired to transition program development to other technologies. All enrolled subjects had completed treatment at the time that the US was impacted by COVID-19.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.