Trial Outcomes & Findings for SB3 Battery Life Observational Study (NCT NCT02382705)

Results Overview

rate at which small bowel is completely examined (capsule endoscopy enters cecum)

Recruitment status

COMPLETED

Target enrollment

57 participants

Primary outcome timeframe

0.1 - 12 hours

Results posted on

2019-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	PillCam SB3EX All participants in the study used the PillCam SB3EX for their capsule endoscopy
Overall Study STARTED	57
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PillCam SB3EX n=57 Participants All participants in the study used the PillCam SB3EX for their capsule endoscopy
Age, Categorical <=18 years	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=57 Participants
Age, Categorical >=65 years	15 Participants n=57 Participants
Age, Continuous	53.6 years STANDARD_DEVIATION 15.7 • n=57 Participants
Sex: Female, Male Female	28 Participants n=57 Participants
Sex: Female, Male Male	29 Participants n=57 Participants
Region of Enrollment Canada	57 participants n=57 Participants

PRIMARY outcome

Timeframe: 0.1 - 12 hours

rate at which small bowel is completely examined (capsule endoscopy enters cecum)

Outcome measures

Outcome measures
Measure	PillCam SB3EX n=57 Participants
Completion Rate (Rate at Which Small Bowel is Completely Examined)	57 Participants

SECONDARY outcome

Timeframe: 0.1 - 12 hours

rate at which a pathological finding is identified on capsule endoscopy

Outcome measures

Outcome measures
Measure	PillCam SB3EX n=57 Participants
Diagnostic Yield	20 Participants

SECONDARY outcome

Timeframe: 0.1 - 12 hours

time it takes for capsule camera to traverse the stomach

Outcome measures

Outcome measures
Measure	PillCam SB3EX n=33 Participants
Gastric Transit Time	37.6 minutes Standard Deviation 92.1

SECONDARY outcome

Timeframe: 0.1 - 12 hours

times it takes for capsule camera to traverse the entire small bowel.

Outcome measures

Outcome measures
Measure	PillCam SB3EX n=33 Participants
Small Bowel Transit Time	232.1 minutes Standard Deviation 98.3

Adverse Events

PillCam SB3EX

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

Dr. Robert Enns

University of British Columbia

Phone: 604 688 6332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place