PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

• Conditions: Colonoscopy

• Registration Number: NCT01480635
• Lead Sponsor: Bethesda Krankenhaus

Brief Summary

Purpose of study:

To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy

Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects

Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy

Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months

Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Subject is >/= 18 years
• Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
• Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum >45 min), adverse reaction to sedation requiring termination of colonoscopy

Exclusion Criteria

• Subject has dysphagia or any swallowing disorder
• Subject has severe congestive heart failure or renal insufficiency
• Subject with high risk for capsule retention
• Subject has a cardiac pacemakers or other implanted electromedical devices
• Subject has any allergy or other contraindication to the medications used in the study
• Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study
• Colonoscopy had been performed by a physician who has experience of <1000 complete colonoscopies
• Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
• Time interval between incomplete colonoscopy and capsule endoscopy >30 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy	One week follow up	Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.

Trial Locations

Locations (6)

Ev. Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany

Gastroenterologische Praxis; 🇩🇪 Düsseldorf, Germany

Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1; 🇩🇪 Frankfurt, Germany

Bethesda Krankenhaus Bergedorf; 🇩🇪 Hamburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen, Germany