PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Bethesda Krankenhaus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by (Responsible Party):
Bethesda Krankenhaus
ClinicalTrials.gov Identifier:
NCT01480635
First received: October 13, 2011
Last updated: November 28, 2011
Last verified: October 2011
  Purpose

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


Condition Phase
Colonoscopy
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Resource links provided by NLM:


Further study details as provided by Bethesda Krankenhaus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.


Estimated Enrollment: 74
Study Start Date: June 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incomplete Colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480635

Contacts
Contact: Martin Keuchel, Dr. +49-40-72554 ext 1201 keuchel@bkb.info
Contact: Peter Baltes, Dr. +49-40-72554 ext 2198 baltes@bkb.info

Locations
Germany
Ev. Krankenhaus Düsseldorf Recruiting
Düsseldorf, Germany, 40217
Contact: Horst Neuhaus, Prof. Dr.    +49-211-919 ext 1605    horst.neuhaus@evk-duesseldorf.de   
Principal Investigator: Horst Neuhaus, Prof. Dr.         
Gastroenterologische Praxis Recruiting
Düsseldorf, Germany, 40227
Contact: Michael Philipper, Dr.    +49-0211-773024    miphi@ish.de   
Principal Investigator: Michael Philipper, Dr.         
Klinikum der J.W. Goethe-Universität, Medizinische Klinik 1 Recruiting
Frankfurt, Germany, 60590
Contact: Jörg Albert, PD Dr.    +49-69-6301 ext 5297    J.Albert@med.uni-frankfurt.de   
Principal Investigator: Jörg Albert, PD Dr.         
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Friedrich Hagenmüller, Prof.Dr.    +49-40-181881 ext 8314    f.hagenmüller@asklepios.com   
Principal Investigator: Friedrich Hagenmüller, Prof. Dr.         
Bethesda Krankenhaus Bergedorf Recruiting
Hamburg, Germany, 21029
Contact: Carola Pflueger    +49-40-72554 ext 1617    pflueger@bkb.info   
Contact    +49-40-72554 ext 1201      
Principal Investigator: Martin Keuchel, Dr.         
Klinikum der Stadt Ludwigshafen am Rhein Recruiting
Ludwigshafen, Germany, 67063
Contact: Matthias Bechtler, Dr.    +49-06215030      
Principal Investigator: Ralf Jakobs, Prof. Dr.         
Sponsors and Collaborators
Bethesda Krankenhaus
Given Imaging Ltd.
Investigators
Principal Investigator: Martin Keuchel, Dr. Bethesda Krankenhaus Bergedorf, Hamburg, Germany
  More Information

No publications provided

Responsible Party: Bethesda Krankenhaus
ClinicalTrials.gov Identifier: NCT01480635     History of Changes
Other Study ID Numbers: PV3467
Study First Received: October 13, 2011
Last Updated: November 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bethesda Krankenhaus:
Incomplete Colonoscopy
Efficacy of PillCam Colon2

ClinicalTrials.gov processed this record on October 23, 2014