PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Colonoscopy Clinical Trial

— PCCE  

Official title:

Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01480635
• Other study ID #: PV3467
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 13, 2011
• Last updated: November 28, 2011
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2011
• Source: Bethesda Krankenhaus
• Contact: Martin Keuchel, Dr.
• Phone: +49-40-72554
• Email: keuchel[@]bkb.info
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonoscopy

Locations

Country	Name	City	State
Germany	Ev. Krankenhaus Düsseldorf	Düsseldorf
Germany	Gastroenterologische Praxis	Düsseldorf
Germany	Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1	Frankfurt
Germany	Asklepios Klinik Altona	Hamburg
Germany	Bethesda Krankenhaus Bergedorf	Hamburg
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen

Sponsors (2)

Lead Sponsor	Collaborator
Bethesda Krankenhaus	Given Imaging Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy	Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.	One week follow up	Yes