Trial Outcomes & Findings for PillCam SB3 Capsule- Feasibility Study (NCT NCT01433042)

NCT ID: NCT01433042

Last Updated: 2019-08-01

Results Overview

precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 225 participants
• Primary outcome timeframe: up to 6 months from end of recruitment
• Results posted on: 2019-08-01

Participant Flow

All patients enrolled in this study were indicated to undergo SB capsule endoscopy and/or had symptoms suggestive of SB disease. 225 patients were enrolled in this study recruitment period: August 2011 till September 2012. recruitment performed at Gastroenterlogy clinics and departments

After obtaining the consent, subjects were assessed for eligibility to participate based on the eligibillity criteria. Each patient underwent a PillCam SB3 procedure. Preparation for the procedure included a 12 hours fast prior to the PillCam SB3ingestion. Patients were allowed to drink clear liquids 2 hours and eat 4 hours post ingestion.

Participant milestones

Measure	Capsule Endoscopy capsule endoscopy : capsule endoscopy procedure
Overall Study STARTED	225
Overall Study COMPLETED	224
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PillCam SB3 Capsule- Feasibility Study

Baseline characteristics by cohort

Measure	Capsule Endoscopy n=225 Participants capsule endoscopy : capsule endoscopy procedure
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	157 Participants n=5 Participants
Age, Categorical >=65 years	67 Participants n=5 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 18.6 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants
Region of Enrollment Spain	66 participants n=5 Participants
Region of Enrollment Romania	19 participants n=5 Participants
Region of Enrollment Israel	76 participants n=5 Participants
Region of Enrollment Sweden	64 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months from end of recruitment

Population: Five (2%) cases were excluded from the efficacy analysis due to the following : * 1 patient withdrawn prior to any procedure. * 1 patient did not meet the inclusion criteria * 3 cases, the capsule remained in the stomach during the entire procedure. Therefore, 220 cases are included in the efficacy analysis.

precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians

Outcome measures

Measure	Capsule Endoscopy n=220 Participants capsule endoscopy : capsule endoscopy procedure
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians	98 percentage of cases

Adverse Events

Capsule Endoscopy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Capsule Endoscopy n=225 participants at risk capsule endoscopy : capsule endoscopy procedure
Cardiac disorders Serious Cardiovascular event	0.44% 1/225 • Number of events 1 • two weeks after capsule procedure

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical affairs

Given Imaging Ltd.

Phone: +972-4-9097774

Email: Hila.Debby@givenimaging.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60