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Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial (CAC)

This study has been withdrawn prior to enrollment.
(Caps became unavailable by manufacturer)
Sponsor:
Information provided by (Responsible Party):
Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT01126632
First received: May 15, 2010
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

Condition
Colonoscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Nova Scotia Health Authority:

Primary Outcome Measures:
  • cap-assisted colonoscopy compared visibility with standard colonoscopy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy.


Secondary Outcome Measures:
  • Polyp detection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Number of Polyps detected per procedure using the cap. To see if it is more visible.

  • Adenoma Detection [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.

  • Advanced lesion detection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    (number of advanced lesions per procedure) defined as lesions with high-grade dysplasia, greater than 1 cm. size. To see if it is more visible using the cap as to not using the cap.

  • Cecal Intubation Rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Time to cecum

  • Total time for colonoscopy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Complication Rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Amount of complications during colonoscopies

  • Procedure indication [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cap Assisted Colonoscopy
Patients receiving colonoscopies where scope is fitted with cap
Standard Colonoscopy
Patients receiving standard colonoscopy without the cap on the scope

Detailed Description:
To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Endoscopy Clinic- Patients already receiving colonoscopies
Criteria

Inclusion Criteria:

  • Patients already booked for a colonoscopy

Exclusion Criteria:

  • History of Colorectal Cancer
  • Severe colitis
  • Cancer
  • poor bowel prep
  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: NCT01126632

Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2Y9
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Donald G MacIntosh, MD Nova Scotia Health Authority
  More Information

Publications:
Responsible Party: Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01126632     History of Changes
Other Study ID Numbers: CAC Study 
Study First Received: May 15, 2010
Last Updated: January 27, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Study was terminated

Keywords provided by Nova Scotia Health Authority:
Colonoscopy

ClinicalTrials.gov processed this record on September 23, 2016