Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03139448
• Collaborator: Revolutionary Medical Devices, Inc. (Other)
• Enrollment: 174
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 37.3

Study Details

Study Description

Brief Summary

Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.

The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.

Condition or Disease	Intervention/Treatment	Phase
Colonoscopy; Oxygenation; Ventilation	Device: Oxygen via nasal cannula; Device: Oxygen via SuperNO2VA nasal mask	N/A

Detailed Description

Colonoscopy has become an essential part of the patient management, especially in the field of colorectal cancer prevention. About 15 million colonoscopies were done in the United States in 2012. Data from United States and European countries suggest that the majority of investigations are performed with the aid of sedation. Since sedation can cause significant respiratory depression, resulting in hypoxia, especially in obese and elder populations who are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal cannula to minimize the risk of hypoxia.

Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.

The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.

Study Design

• Study Type: Interventional
• Actual Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy: a Prospective Randomized Trial
• Actual Study Start Date: May 17, 2017
• Actual Primary Completion Date: Oct 6, 2017
• Actual Study Completion Date: Oct 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxygen via nasal cannula (Standard of Care) The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.	Device: Oxygen via nasal cannula; Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
Experimental: Oxygen via SuperNO2VA nasal mask The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.	Device: Oxygen via SuperNO2VA nasal mask; The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.

Outcome Measures

Primary Outcome Measures

1. Time to First Intervention [Usually 5 minutes]

   The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.

Secondary Outcome Measures

1. Number of Subjects Receiving Interventions for Airway Management [Duration of colonoscopy procedure (usually 30 minutes)]

   Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion

2. Duration of Intervention [Duration of colonoscopy procedure (usually 30 minutes)]

   Duration of intervention

3. Oxygen Saturation Reading- Median [Duration of colonoscopy procedure (usually 30 minutes)]

   Oxygen saturation reading- Median

4. Oxygen Saturation- Lowest Reading [Duration of colonoscopy procedure (usually 30 minutes)]

   Oxygen saturation- Lowest reading

5. Number of Participants With Oxygen Saturation- Reading Below 90% [Duration of colonoscopy procedure (usually 30 minutes)]

   Number of participants with oxygen saturation- reading below 90%

6. Tidal Volume (VT) [Duration of colonoscopy procedure (usually 30 minutes)]

   Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.

7. Respiratory Rate (RR) [Duration of colonoscopy procedure (usually 30 minutes)]

   Respiratory Rate (RR)

8. Minute Ventilation (MV) [Duration of colonoscopy procedure (usually 30 minutes)]

   Minute ventilation (MV)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients 18 years or older

• BMI of 30-50

• ASA 1-3 Scheduled for colonoscopy with sedation

Exclusion Criteria:

• Untreated ischemic heart disease

• Acute and chronic respiratory disorders, including COPD and asthma

• Emergent procedures

• Planned use of an invasive airway (ie: supra-glottic device, LMA, etc)

• Pregnant women

• Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing

• Patient refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt University Medical Center
• Revolutionary Medical Devices, Inc.

Investigators

• Principal Investigator: Koffi M Kla, M.D., Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 26, 2017

More Information

Publications

None provided.

• Responsible Party: Koffi Michael Kla, Associate Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03139448
• Other Study ID Numbers: 170488
• First Posted: May 4, 2017
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Period Title: Overall Study
STARTED	85	89
Intervention Started	79	70
COMPLETED	73	63
NOT COMPLETED	12	26

Baseline Characteristics

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask	Total
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.	Total of all reporting groups
Overall Participants	73	63	136
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	61 83.6%	50 79.4%	111 81.6%
>=65 years	12 16.4%	13 20.6%	25 18.4%
Sex: Female, Male (Count of Participants)
Female	47 64.4%	33 52.4%	80 58.8%
Male	26 35.6%	30 47.6%	56 41.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	73 100%	63 100%	136 100%

Outcome Measures

1. Primary Outcome

Title	Time to First Intervention
Description	The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.
Time Frame	Usually 5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Mean (Standard Deviation) [minutes]	10 (12)	19 (10)

2. Secondary Outcome

Title	Number of Subjects Receiving Interventions for Airway Management
Description	Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Count of Participants [Participants]	46 63%	14 22.2%

3. Secondary Outcome

Title	Duration of Intervention
Description	Duration of intervention
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Mean (Standard Deviation) [minutes]	19 (28)	12 (31)

4. Secondary Outcome

Title	Oxygen Saturation Reading- Median
Description	Oxygen saturation reading- Median
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Baseline	100.0	100
2 minutes after induction	98	100
4 minutes after induction	99	100
6 minutes after induction	99	100
5 minutes before end of procedure	99	100
end of procedure	98	100

5. Secondary Outcome

Title	Oxygen Saturation- Lowest Reading
Description	Oxygen saturation- Lowest reading
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Baseline	99.11 (1.76)	99.23 (1.53)
2 minutes after induction	96.22 (6.12)	99.31 (1.47)
4 minutes after induction	97.57 (4.79)	99.39 (1.21)
6 minutes after induction	98.17 (3.32)	99.52 (0.82)
5 minutes before end of procedure	97.76 (2.66)	99.33 (1.03)
end of procedure	97.94 (2.11)	99.19 (1.11)

6. Secondary Outcome

Title	Number of Participants With Oxygen Saturation- Reading Below 90%
Description	Number of participants with oxygen saturation- reading below 90%
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Count of Participants [Participants]	16 21.9%	3 4.8%

7. Secondary Outcome

Title	Tidal Volume (VT)
Description	Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Baseline	1032.80 (583.74)	1011.39 (462.30)
2 minutes after induction	527.01 (367.54)	625.31 (380.17)
4 minutes after induction	533.26 (467.47)	589.22 (380.58)
6 minutes after induction	540.16 (417.28)	613.15 (510.71)
5 minutes before end of procedure	610.38 (584.06)	735.76 (614.42)
end of procedure	724.72 (538.90)	879.52 (650.92)

8. Secondary Outcome

Title	Respiratory Rate (RR)
Description	Respiratory Rate (RR)
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Baseline	15.07 (4.57)	15.36 (4.15)
2 minutes after induction	15.15 (5.32)	15.21 (4.39)
4 minutes after induction	17.77 (5.36)	16.95 (4.57)
6 minutes after induction	18.70 (4.87)	17.48 (4.77)
5 minutes before end of procedure	18.39 (5.17)	17.02 (4.40)
end of procedure	17.69 (4.5)	17.50 (5.63)

9. Secondary Outcome

Title	Minute Ventilation (MV)
Description	Minute ventilation (MV)
Time Frame	Duration of colonoscopy procedure (usually 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)	Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.	The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
Measure Participants	73	63
Baseline	14.29 (8.01)	14.52 (6.31)
2 minutes after induction	8.41 (6.44)	9.16 (5.96)
4 minutes after induction	8.82 (6.86)	9.62 (6.76)
6 minutes after induction	9.36 (5.99)	9.94 (8.06)
5 minutes before end of procedure	10.29 (8.27)	12.18 (10.82)
end of procedure	12.21 (9.19)	13.48 (9.01)

Adverse Events

Time Frame	From the beginning of the study until discharge from the Post Anesthesia Recovery Room (Usually 2 hours)
Arm/Group Title	Oxygen Via Nasal Cannula (Standard of Care)		Oxygen Via SuperNO2VA Nasal Mask
Arm/Group Description	The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center. Oxygen via nasal cannula: Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.		The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O. Oxygen via SuperNO2VA nasal mask: The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
All Cause Mortality
	Oxygen Via Nasal Cannula (Standard of Care)		Oxygen Via SuperNO2VA Nasal Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/70 (0%)
Serious Adverse Events
	Oxygen Via Nasal Cannula (Standard of Care)		Oxygen Via SuperNO2VA Nasal Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Oxygen Via Nasal Cannula (Standard of Care)		Oxygen Via SuperNO2VA Nasal Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/70 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.