Trial Outcomes & Findings for Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease (NCT NCT01787825)
NCT ID: NCT01787825
Last Updated: 2017-05-10
Results Overview
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
COMPLETED
NA
121 participants
Study Completion
2017-05-10
Participant Flow
Subjects recruited from population of patients prescribed capsule endoscopy for OGIB
Participant milestones
| Measure |
CapsoCam SV-1 Then PillCam SB2
Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
|
PillCam SB2 Then CapsoCam SV-1
Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
54
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
CapsoCam SV-1 Then PillCam SB2
Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
|
PillCam SB2 Then CapsoCam SV-1
Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
|
|---|---|---|
|
Overall Study
Subject Did Not Ingest Capsules
|
1
|
0
|
|
Overall Study
Data Not Analyzable
|
5
|
1
|
Baseline Characteristics
Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=120 Participants
PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy
The analysis population consisted of subjects that swallowed the capsules.
|
|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 15.42 • n=39 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Study CompletionPopulation: Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
Outcome measures
| Measure |
CapsoCam SV-1
n=114 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
PillCam SB2
n=114 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
|---|---|---|
|
Normal vs Abnormal, Overall Impression
Abnormal
|
42 participants
|
42 participants
|
|
Normal vs Abnormal, Overall Impression
Normal
|
72 participants
|
72 participants
|
SECONDARY outcome
Timeframe: Study CompletionPopulation: For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.
Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.
Outcome measures
| Measure |
CapsoCam SV-1
n=112 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
PillCam SB2
n=110 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
|---|---|---|
|
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
|
4.1 hours
Standard Deviation 1.85
|
3.6 hours
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: Study CompletionComparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.
Outcome measures
| Measure |
CapsoCam SV-1
n=114 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
PillCam SB2
n=114 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
|---|---|---|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Other
|
2 participants
|
2 participants
|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Normal
|
71 participants
|
70 participants
|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Vascular
|
24 participants
|
21 participants
|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Mass/Polyp
|
1 participants
|
4 participants
|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Blood
|
1 participants
|
3 participants
|
|
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Ulcerative
|
15 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Study CompletionPopulation: For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.
Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects
Outcome measures
| Measure |
CapsoCam SV-1
n=113 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
PillCam SB2
n=113 Participants
Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
|
|---|---|---|
|
Preference Between CapsoCam SV-1 and PillCam SB2
|
89 participants
|
24 participants
|
Adverse Events
All Study Participants
Serious adverse events
| Measure |
All Study Participants
n=120 participants at risk
PillCam SB Capsule and CapsoCam SV-1
|
|---|---|
|
Gastrointestinal disorders
Capsule Endoscope Retention
|
1.7%
2/120 • Number of events 2 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
Other adverse events
| Measure |
All Study Participants
n=120 participants at risk
PillCam SB Capsule and CapsoCam SV-1
|
|---|---|
|
Gastrointestinal disorders
GI Tract discomfort or pain and nausea
|
5.0%
6/120 • Number of events 6 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
|
Gastrointestinal disorders
Malaise
|
0.83%
1/120 • Number of events 1 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
|
Skin and subcutaneous tissue disorders
Skin Irritation and Itchiness
|
1.7%
2/120 • Number of events 2 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
|
Gastrointestinal disorders
Delayed Capsule Excretion
|
0.83%
1/120 • Number of events 1 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
|
Renal and urinary disorders
Right Kidney Pain
|
0.83%
1/120 • Number of events 1 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
|
Nervous system disorders
Migraine Headache
|
0.83%
1/120 • Number of events 1 • Within 30 days of Subjects' Swallowing of both cpasules: CapsoCam SV-1 and PillCam SB2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place