PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

NCT01480635 | Unknown DMC

• 1 other identifier: PV3467
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 6

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

Conditions

Colonoscopy

Keywords

Incomplete Colonoscopy; Efficacy of PillCam Colon2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Incomplete Colonoscopy

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bethesda Krankenhaus: lead
• Medtronic - MITG: collaborator

Study Sites (6)

Bethesda Krankenhaus Bergedorf

Hamburg, Hamburg, 21029, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, Hamburg, 22763, Germany

RECRUITING

Ev. Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

RECRUITING

Gastroenterologische Praxis

Düsseldorf, 40227, Germany

RECRUITING

Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1

Frankfurt, 60590, Germany

RECRUITING

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen, 67063, Germany

RECRUITING

Study Officials

• Martin Keuchel, Dr.

  Bethesda Krankenhaus Bergedorf, Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Keuchel, Dr.

CONTACT

+49-40-72554; keuchel@bkb.info

Peter Baltes, Dr.

CONTACT

+49-40-72554; baltes@bkb.info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: November 29, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 29, 2011

Record last verified: 2011-10

Locations

DE (6)