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

October 13, 2011
November 28, 2011
June 2010
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01480635 on ClinicalTrials.gov Archive Site
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PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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

Colonoscopy
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Incomplete Colonoscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
October 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Martin Keuchel, Dr. +49-40-72554 ext 1201 keuchel@bkb.info
Contact: Peter Baltes, Dr. +49-40-72554 ext 2198 baltes@bkb.info
Germany
 
NCT01480635
PV3467
Yes
Bethesda Krankenhaus
Bethesda Krankenhaus
Given Imaging Ltd.
Principal Investigator: Martin Keuchel, Dr. Bethesda Krankenhaus Bergedorf, Hamburg, Germany
Bethesda Krankenhaus
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP