Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule

NCT06515171 | Active Not Recruiting

• 1 other identifier: 0292-19-TLV
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the success rate of a second bowel preparation protocol for patency capsule (PC) in Crohn Disease (CD) patients who failed to pass an initial protocol PC on a previous attempt. The main question it aims to answer is what is the percentage of patients successfully passing the second PC test, among those who failed the first attempt. Participants who will fail the PC test will be scheduled for another test with a different preparation protocol. Participants will be asked to report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing. .

Conditions

Crohn Disease; Crohn Disease of Small Intestine

Outcome Measures

Primary Outcomes (1)

• Rate of second PC passaging

  The percentage of patients successfully passing the second PC test, among those who fail the first attempt.

  3 years

Secondary Outcomes (4)

• PC retention

  3 years

• VCE retention

  3 years

• Positive PC passage

  3 years

• Risk factors

  4 years

Study Arms (2)

CD patients referred for PC before VCE

No intervention will be administered. Endoscopic capsule protocol will be performed in a uniform manner on all participants in the study as part of their routine clinical evaluation regardless of the study. The patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing

CD patients who failed to pass an initial protocol PC on a previous attempt.

All the patients who failed the PC test will be scheduled for another test with a different preparation protocol, a common practice also today. This will be done as a standard procedure, in the clinical setting of the endoscopic capsule clinic and not as part of the study. Again, the patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing. If the second test was positive as well, an abdominal x-ray will be performed within 2 weeks to rule out PC retention - standard protocol for PC retention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CD patients referred for PC before VCE

You may qualify if:

• Crohn Disease patients intendent to perform Capsule endoscopy .

You may not qualify if:

• Severe obstructive symptoms according to physician discretion
• Pregnancy
• Inability to sign informed consent
• Inability to complete the VCE procedure

Sponsors & Collaborators

• Shmuel Kivity, MD: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nitsan Maharshak, MD

  Sourasky Medical Center and Tel-Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: September 11, 2019
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)