Trial Outcomes & Findings for Evaluation of PillCam® Express Capsule Endoscopy Delivery System (NCT NCT01088646)
NCT ID: NCT01088646
Last Updated: 2020-10-22
Results Overview
The number of capsules that successfully were in the duodenum as indicated by video images
COMPLETED
NA
25 participants
up to 7 days
2020-10-22
Participant Flow
3 hospital sites
Participant milestones
| Measure |
PillCam Express Capsule Delivery System
PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of PillCam® Express Capsule Endoscopy Delivery System
Baseline characteristics by cohort
| Measure |
PillCam Express Capsule Delivery System
n=25 Participants
PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 18.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 7 daysThe number of capsules that successfully were in the duodenum as indicated by video images
Outcome measures
| Measure |
Pillcam Express Capsule Delivery System
n=25 Participants
The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
|
|---|---|
|
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
|
25 participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Physicians completed questionnaires for each of the 25 subjects. The questions were divided to two: physicians assessment A where 'YES' is associated with a smooth procedure (4 questions x 25 subjects = 100 Y/N assessments) and physicians B where 'no' is associated with smooth procedure (6 questions x 25 subjects = 150 Y/N assessment).
The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions.
Outcome measures
| Measure |
Pillcam Express Capsule Delivery System
n=250 Y/N questions
The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
|
|---|---|
|
Physician's Subjective Assessment of the Ease of Capsule Placement
Physician Assessment A
|
94 assessments
|
|
Physician's Subjective Assessment of the Ease of Capsule Placement
Physician Assessment B
|
126 assessments
|
Adverse Events
PillCam Express Capsule Delivery System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PillCam Express Capsule Delivery System
n=25 participants at risk
PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
|
|---|---|
|
Gastrointestinal disorders
capsule failed to deploy in first attempt
|
4.0%
1/25 • Number of events 1 • Adverse Event information was collected from screening (up to -14 day prior to procedure) through follow up phone contact at 5-10 days after the procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place