Trial Outcomes & Findings for The Second-Generation MCCG for Upper Gastrointestinal Tract. (NCT NCT03977935)
NCT ID: NCT03977935
Last Updated: 2020-10-27
Results Overview
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Through end of examination, up to 30 minutes
Results posted on
2020-10-27
Participant Flow
Participant milestones
| Measure |
The First-generation MCCG Group
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Second-Generation MCCG for Upper Gastrointestinal Tract.
Baseline characteristics by cohort
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.45 years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
48.58 years
STANDARD_DEVIATION 14.24 • n=7 Participants
|
48.51 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Indication
Abdominal pain or distension
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Indication
Acid reflux or nausea/vomit
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Indication
Chronic diarrhea
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Indication
Physical examination
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Helicobacter pylori (Hp) infection
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
History of abdominal surgery, smoking and drinking
History of abdominal surgery
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
History of abdominal surgery, smoking and drinking
Smoking history
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
History of abdominal surgery, smoking and drinking
Drinking history
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through end of examination, up to 30 minutesCircumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Circumferential Visualization of the Z-line
100% of Z-line
|
0 Participants
|
5 Participants
|
|
Circumferential Visualization of the Z-line
≥50% of Z-line
|
5 Participants
|
7 Participants
|
|
Circumferential Visualization of the Z-line
<50% of Z-line
|
12 Participants
|
12 Participants
|
|
Circumferential Visualization of the Z-line
0% of Z-line
|
23 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: up to 2 days after the examinationDetection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Detection Rate of Duodenal Papilla
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Through end of examination, up to 30 minutesRecord the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Gastric Examination Time (GET)
|
7.78 minutes
Standard Deviation 0.97
|
5.24 minutes
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: up to 10 minutes after the examinationThe performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Manipulation Performance Score of the MCCG
Fluency
|
3.04 score on a scale
Standard Deviation 0.51
|
4.59 score on a scale
Standard Deviation 0.42
|
|
Manipulation Performance Score of the MCCG
Comfortableness
|
3.16 score on a scale
Standard Deviation 0.45
|
4.51 score on a scale
Standard Deviation 0.43
|
|
Manipulation Performance Score of the MCCG
Stability
|
3.84 score on a scale
Standard Deviation 0.55
|
4.17 score on a scale
Standard Deviation 0.50
|
|
Manipulation Performance Score of the MCCG
Total score
|
10.05 score on a scale
Standard Deviation 1.04
|
13.28 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: up to 30 minutes after the examinationAssess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Image Quality Score (Mainly Focus on Clarity)
|
7.90 score on a scale
Standard Deviation 0.61
|
8.63 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: up to 30 minutes after the examinationThe number of images captured by MCCG for esophagus and Z-line.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
The Number of Images Captured for Esophagus and Z-line
The number of images captured for esophagus
|
97 images
Interval 42.0 to 160.25
|
171 images
Interval 81.25 to 409.25
|
|
The Number of Images Captured for Esophagus and Z-line
The number of images captured for Z-line
|
0 images
Interval 0.0 to 2.75
|
2 images
Interval 0.0 to 13.0
|
SECONDARY outcome
Timeframe: up to 2 days after the examinationcalculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Number of Participants With Lesions in Upper Gastrointestinal Tract
Inflammation
|
25 Participants
|
24 Participants
|
|
Number of Participants With Lesions in Upper Gastrointestinal Tract
Focal lesions
|
12 Participants
|
13 Participants
|
|
Number of Participants With Lesions in Upper Gastrointestinal Tract
normal
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 2 days after the examinationAssess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
Gastric transit time (min)
|
53.09 minutes
Interval 22.88 to 90.84
|
48.35 minutes
Interval 19.09 to 78.83
|
|
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
Small-bowel transit time (min)
|
327.60 minutes
Interval 260.73 to 394.55
|
297.22 minutes
Interval 239.68 to 369.27
|
|
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
Total running time (min)
|
702.83 minutes
Interval 648.47 to 856.1
|
1001.99 minutes
Interval 774.42 to 1207.38
|
SECONDARY outcome
Timeframe: Through end of examination, up to 30 minutesThe bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Cleansing Level Score of Z-line Area
No bubbles
|
13 Participants
|
11 Participants
|
|
Cleansing Level Score of Z-line Area
A few bubbles
|
18 Participants
|
22 Participants
|
|
Cleansing Level Score of Z-line Area
Increased amount of bubbles
|
7 Participants
|
5 Participants
|
|
Cleansing Level Score of Z-line Area
Severe bubbles
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 2 weeks after the examinationThe presence of adverse events within two weeks aftter swallowing MCCG will be recorded.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
The Incidence of Adverse Events (The Safety of MCCG)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 2 days after the examinationAssess the transit time of MCCG in esophagus from starts take images to ends.
Outcome measures
| Measure |
The First-generation MCCG Group
n=40 Participants
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
|
The Second-generation MCCG Group
n=40 Participants
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
|
|---|---|---|
|
Transit Time of MCCG in Esophagus
|
59.5 seconds
Interval 24.75 to 82.75
|
44.5 seconds
Interval 23.0 to 107.5
|
Adverse Events
The First-generation MCCG Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The Second-generation MCCG Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place