PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy (PCCE)

November 28, 2011 updated by: Bethesda Krankenhaus

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Martin Keuchel, Dr.
  • Phone Number: 1201 +49-40-72554
  • Email: keuchel@bkb.info

Study Contact Backup

  • Name: Peter Baltes, Dr.
  • Phone Number: 2198 +49-40-72554
  • Email: baltes@bkb.info

Study Locations

  • Germany
      • Düsseldorf, Germany, 40217
        • Recruiting
        • Ev. Krankenhaus Düsseldorf
        • Contact:
        • Principal Investigator:
          • Horst Neuhaus, Prof. Dr.
      • Düsseldorf, Germany, 40227
        • Recruiting
        • Gastroenterologische Praxis
        • Contact:
          • Michael Philipper, Dr.
          • Phone Number: +49-0211-773024
          • Email: miphi@ish.de
        • Principal Investigator:
          • Michael Philipper, Dr.
      • Frankfurt, Germany, 60590
        • Recruiting
        • Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1
        • Contact:
        • Principal Investigator:
          • Jörg Albert, PD Dr.
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
        • Contact:
        • Principal Investigator:
          • Friedrich Hagenmüller, Prof. Dr.
      • Hamburg, Germany, 21029
        • Recruiting
        • Bethesda Krankenhaus Bergedorf
        • Contact:
        • Contact:
          • Phone Number: 1201 +49-40-72554
        • Principal Investigator:
          • Martin Keuchel, Dr.
      • Ludwigshafen, Germany, 67063
        • Recruiting
        • Klinikum der Stadt Ludwigshafen am Rhein
        • Contact:
          • Matthias Bechtler, Dr.
          • Phone Number: +49-06215030
        • Principal Investigator:
          • Ralf Jakobs, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Incomplete Colonoscopy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bethesda Krankenhaus

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Martin Keuchel, Dr., Bethesda Krankenhaus Bergedorf, Hamburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PV3467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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