Performance Evaluation of the GIVEN Patency System

Not Applicable

• Conditions: Patients with known small bowel strictures; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12605000670673
• Lead Sponsor: Given Imaging Ltd., New Industrial Park, Yoqneam, Israel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patient is known to suffer from intestinal stricture based on an X-ray test, and/or SBFT and/or abdominal CT scan performed within the last 3 months [these tests will be repeated only if there are recent changes in the patients clinical conditions during this period. 2. Patient is able and agrees to sign the Informed Consent Form.

Exclusion Criteria

1. Patient suffers from swallowing disorders 2. Patient has less than 2 bowel movements per week (to be confirmed by bowel movement log)3. Female patient is pregnant (women of childbearing potential will have to perform a urine pregnancy test before the ingestion).4. Patient has any condition, which precludes compliance with study and/or device instructions.5.Patient has cardiac pacemakers or other electro medical implant6.Patient suffers from life threatening conditions7.Patient is currently participating in another clinical study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the performance of the GIVEN Patency System by demonstrating its ability to verify the patency of the gastro-intestinal (GI) tract in patients in whom strictures have been identified by conventional modalities such as small-bowel-follow-through (SBFT), CT-scan, etc[];The transit time of capsules and/or tags from ingestion to excretion. [];For cases where the GIVEN Patency System finds the GI patent: smooth passage of PillCam SB video Capsule without delay or retention[]

Secondary Outcome Measures

Name	Time	Method
umber and severity of adverse events directly related to the use of the GIVEN Patency System.[];The location and conditions of the capsule as assessed by fluoroscopy procedure.[];The condition of the capsule following excretion.[]