Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02091440
• Collaborator: (none)
• Enrollment: 6
• Locations: 5
• Arm: 1
• Duration (Months): 57.2
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Implant of the HW005 Ventricular Assist System.	N/A

Detailed Description

The primary endpoint is success at 180 days which is expressed as a simple proportion and defined as alive on the originally implanted HW005 or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful. The primary endpoint is not statistically powered. The six eligible implanted cases will be evaluated as a proportion of success accompanied by a 95% exact confidence interval and presented alongside the ADVANCE results for visual comparison.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Dec 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: HW005 Ventricular Assist System Implant of the HW005 Ventricular Assist System.	Device: Implant of the HW005 Ventricular Assist System.; The HW005 Pump is in implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days [180 days]

   The primary endpoint is success at 180 days which is defined as alive on the originally implanted HW005 Ventricular Assist System or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful.

Secondary Outcome Measures

1. Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days [180 days]

2. Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) [Through study completion, an average of 44.5 months]

   SAEs are defined as events that result in death, are life-threatening, result in permanent disability, require medical treatment to prevent permanent disability or require surgical intervention or hospitalization. UADEs are defined as any serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report. Events were categorized using the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) definitions.

3. Incidence of All Device Failures and Device Malfunctions. [Through study completion, an average of 44.5 months]

   The device failures and malfunctions are the failures on pumping function due to thrombosis inside/outside of the implanted pump, the mechanical failures of the implanted components, the mechanical failures of the external components and the failures due to the user. Events were categorized using the J-MACS definitions.

4. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months [Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)]

   The KCCQ is a self-evaluation questionnaire for patients with heart failure to assess the severity of their symptoms how it may affect their lives. Scores range between 0 (worst) - 100 (best). Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening. The positive change in KCCQ score indicates an improvement in patient Quality of Life.

5. Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months [Screening, Month 6 (180 days) and Month 24 (after FU completion)]

   The New York Heart Association (NYHA) Functional Classification places patients with heart failure in one of four categories based on how much they are limited during physical activity. Class I (best): No limitation of physical activity. Class II: Slight limitation of physical activity. Comfortable at rest. Class III: Marked limitation of physical activity. Comfortable at rest. Class IV (worst): Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. A shift from a higher class (e.g. Class IV) to a lower class (e.g. Class II) indicates an improvement in patient health and functional status.

6. Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months [Screening, Month 6 (180 days) and Month 24 (after FU completion)]

   For the 6-minute walk test, the patient is asked to walk for 6 minutes. The total distance walked is measured. Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening. A positive change in 6-minute walk distance indicates an improvement in health and functional status.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with irreversible end-stage heart failure of New York Heart Association (NYHA) class III or IV and a history of class IV who are eligible for heart transplantation.

2. Patients who are dependent on medication of inotropes or intra-aortic balloon pump (IABP).

3. Body Surface Area (BSA) ≥1.2 m2. In addition other factors may be taken into consideration, including chest size, abdominal fat (lack of abdominal fat may preclude a pump pocket) and any other physical characteristics that might be benefited by an intra-pericardial pump in a small person.

4. Patients who are aged less than 65 years of age.

5. Patients must be able to understand the limits and complications associated with the HW005 Ventricular Assist System.

6. Female patients of childbearing potential must agree on contraception for the duration of the study.

7. The patient or the legal representative has signed the informed consent form.

Exclusion Criteria:

1. Severe illness other than heart disease which would exclude cardiac transplantation.

2. Inadequate family/social support.

3. Active, uncontrolled infection despite appropriate antibiotic, antiviral or antifungal treatment.

4. Existence of any ongoing mechanical circulatory support (MCS) other than an IABP.

5. Prior cardiac transplant or cardiomyoplasty.

6. Acute myocardial infarction within 14 days of implant.

7. Uncorrected thrombocytopenia or generalized coagulopathy.

8. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.

9. Patients for whom the use of a left ventricular assist device (LVAD) is contraindicated due to an ongoing aortic/cardiac aneurysm, intraventricular septum rupture and/or use of a mechanical heart valve.

10. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.

11. Patients with irreversible hepatic dysfunction.

12. Patients with irreversible renal dysfunction.

13. Pregnancy.

14. Patients with serious chronic obstructive pulmonary disease (COPD) (Forced Expiratory Volume in the first second (FEV1) < 50%).

15. Pulmonary vascular resistance is unresponsive (fixed) to pharmacologic manipulation as demonstrated by a pulmonary artery systolic pressure exceeding 60mmHg in conjunction with any one of the two following variables:

• Pulmonary vascular resistance is greater than 6 Woods Units or

• Transpulmonary gradient exceeds 15 mmHg

1. Cardiothoracic surgery within 14 days of implantation.

2. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.

3. Pulmonary embolus within three weeks of enrollment as documented by computed tomography (CT) scan or nuclear scan.

4. Patients have moderate to severe aortic insufficiency without plans for correction during pump implantation surgery. Correction may include aortic valve repair at the time of implant.

5. The patient who has advanced calcification in the ascending aorta and/or the descending aorta.

6. Serious right heart failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) at the time of screening.

7. Patients with severe central nervous system disorder or severe cerebral vascular disorder.

8. Patients with a history of drug intoxication, alcohol dependence.

9. Patients unwilling or unable to comply with study requirements.

10. Patients who refuse transfusion.

11. Patients who in the investigator judgement are deemed to be unsuitable as a subject.

12. Patients who are participating in another clinical trial involving investigational drugs or devices.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyushu University Hospital	Fukuoka	Kyushu	Japan	812-8582
2	Tohoku University Hospital	Sendai	Tohoku	Japan	980-8547
3	Osaka University Hospital	Osaka		Japan	565-0871
4	National Cerebral and Cardiovascular Center Hospital	Osaka		Japan	565-8565
5	The University of Tokyo Hospital	Tokyo		Japan	113-8655

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Yoshiki Sawa, MD, Osaka University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02091440
• Other Study ID Numbers: HW005/ Japan
• First Posted: Mar 19, 2014
• Last Update Posted: Sep 9, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Medical Device; Thoracic Surgical Procedure; Pumps Heart Assist; Ventricular Assist Device
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Period Title: Overall Study
STARTED	6
Primary Endpoint (Success at 180 Days)	6
Overall Survival at 180 Days	6
COMPLETED	4
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 50%
Male	3 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	6 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Japan	6 100%
New York Heart Association (NYHA) Classification (Count of Participants)
Class I	0 0%
Class II	0 0%
Class III	3 50%
Class IV	3 50%
Six-Minute Walk Test (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]	135.8 (160.12)
Kansas City Cardiomyopathy Questionnaire (KCCQ) scores (units on a scale) [Mean (Standard Deviation) ]
KCCQ Physical Limitation	45.0 (31.69)
KCCQ Symptom Stability	37.5 (26.22)
KCCQ Self-Efficacy	75.0 (22.36)
KCCQ Quality of Life	31.9 (27.09)
KCCQ Social Limitation	9.4 (13.26)
KCCQ Overall Summary Score	45.5 (28.44)
KCCQ Clinical Summary Score	56.4 (33.89)
KCCQ Symptom Frequency	66.0 (39.91)
KCCQ Symptom Burden	69.4 (38.97)
KCCQ Total Symptom Score	67.7 (39.32)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days
Description	The primary endpoint is success at 180 days which is defined as alive on the originally implanted HW005 Ventricular Assist System or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Count of Participants [Participants]	6 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion
	Estimated Value	100
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Count of Participants [Participants]	6 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Kaplan-Meier Survival
	Estimated Value	100
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Description	SAEs are defined as events that result in death, are life-threatening, result in permanent disability, require medical treatment to prevent permanent disability or require surgical intervention or hospitalization. UADEs are defined as any serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report. Events were categorized using the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) definitions.
Time Frame	Through study completion, an average of 44.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
J-MACS SAEs	1.24
UADEs	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence
	Estimated Value	1.24
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Incidence of All Device Failures and Device Malfunctions.
Description	The device failures and malfunctions are the failures on pumping function due to thrombosis inside/outside of the implanted pump, the mechanical failures of the implanted components, the mechanical failures of the external components and the failures due to the user. Events were categorized using the J-MACS definitions.
Time Frame	Through study completion, an average of 44.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Number [event rate per patient year]	1.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence
	Estimated Value	1.66
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months
Description	The KCCQ is a self-evaluation questionnaire for patients with heart failure to assess the severity of their symptoms how it may affect their lives. Scores range between 0 (worst) - 100 (best). Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening. The positive change in KCCQ score indicates an improvement in patient Quality of Life.
Time Frame	Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Month 6	22.2 (12.55)
Month 24	19.4 (11.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Change from baseline
	Estimated Value	19.4
	Confidence Interval	(2-Sided) 95%; 7.5 to 31.4
	Parameter Dispersion	Type: Standard Deviation; Value: 11.39
	Estimation Comments	Confidence interval based on t-distribution.

6. Secondary Outcome

Title	Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months
Description	The New York Heart Association (NYHA) Functional Classification places patients with heart failure in one of four categories based on how much they are limited during physical activity. Class I (best): No limitation of physical activity. Class II: Slight limitation of physical activity. Comfortable at rest. Class III: Marked limitation of physical activity. Comfortable at rest. Class IV (worst): Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. A shift from a higher class (e.g. Class IV) to a lower class (e.g. Class II) indicates an improvement in patient health and functional status.
Time Frame	Screening, Month 6 (180 days) and Month 24 (after FU completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Class I	0 0%
Class II	0 0%
Class III	3 50%
Class IV	3 50%
Class I	1 16.7%
Class II	5 83.3%
Class III	0 0%
Class IV	0 0%
Class I	2 33.3%
Class II	3 50%
Class III	1 16.7%
Class IV	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage change
	Estimated Value	-83.33
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%

7. Secondary Outcome

Title	Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months
Description	For the 6-minute walk test, the patient is asked to walk for 6 minutes. The total distance walked is measured. Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening. A positive change in 6-minute walk distance indicates an improvement in health and functional status.
Time Frame	Screening, Month 6 (180 days) and Month 24 (after FU completion)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
Measure Participants	6
Month 6	198.2 (217.01)
Month 24	130.0 (275.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	HW005 Ventricular Assist System
	Comments
	Type of Statistical Test	Other
	Comments	Single group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Change from baseline
	Estimated Value	130.0
	Confidence Interval	(2-Sided) 95%; -158.9 to 418.9
	Parameter Dispersion	Type: Standard Deviation; Value: 275.32
	Estimation Comments	Confidence interval based on t-distribution.

Adverse Events

Time Frame	Through study completion, an average of 44.5 months
Arm/Group Title	HW005 Ventricular Assist System
Arm/Group Description	Implant of the HW005 Ventricular Assist System.: The HW005 Pump is an implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
All Cause Mortality
	HW005 Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
Serious Adverse Events
	HW005 Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	5/6 (83.3%)
Cardiac disorders
Ventricular Cardiac Arrhythmia	2/6 (33.3%)	2
Supraventricular Cardiac Arrhythmia	2/6 (33.3%)	3
Pericardial Fluid Collection	2/6 (33.3%)	2
Right Heart Failure requiring inotropic therapy	1/6 (16.7%)	2
General disorders
Other	3/6 (50%)	5
Infections and infestations
Sepsis	1/6 (16.7%)	2
Driveline Exit Site Infection	1/6 (16.7%)	1
Injury, poisoning and procedural complications
Bleeding requiring re-hospitalization	2/6 (33.3%)	2
Bleeding requiring re-operation	2/6 (33.3%)	2
Renal and urinary disorders
Chronic Renal Dysfunction	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Dysfunction	1/6 (16.7%)	1
Vascular disorders
Hemorrhagic Cerebrovascular Accident	1/6 (16.7%)	3
Other (Not Including Serious) Adverse Events
	HW005 Ventricular Assist System
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Cardiac disorders
Ventricular Cardiac Arrhythmia	3/6 (50%)	3
Supraventricular Cardiac Arrhythmia	3/6 (50%)	4
Pericardial Fluid Collection	2/6 (33.3%)	2
Right Heart Failure requiring inotropic therapy	1/6 (16.7%)	2
General disorders
Other	6/6 (100%)	86
Infections and infestations
Sepsis	1/6 (16.7%)	2
Driveline Exit Site Infection	2/6 (33.3%)	2
Injury, poisoning and procedural complications
Bleeding requiring re-hospitalization	2/6 (33.3%)	2
Bleeding requiring re-operation	2/6 (33.3%)	2
Product Issues
Device Malfunction/Failure	2/6 (33.3%)	5
Renal and urinary disorders
Acute Renal Dysfunction	1/6 (16.7%)	1
Chronic Renal Dysfunction	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Dysfunction	1/6 (16.7%)	1
Vascular disorders
Hemorrhagic Cerebrovascular Accident	1/6 (16.7%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI cannot disclose the trial results without the sponsor's permission. The disclosure restriction is not limited by a set period.