NCT01126632

Brief Summary

Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

May 15, 2010

Last Update Submit

January 27, 2016

Conditions

Colonoscopy

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • cap-assisted colonoscopy compared visibility with standard colonoscopy

    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.

    4 months

Secondary Outcomes (7)

  • Polyp detection rate

    4 months

  • Adenoma Detection

    4 months

  • Advanced lesion detection rate

    4 months

  • Cecal Intubation Rate

    4 months

  • Total time for colonoscopy

    4 months

  • +2 more secondary outcomes

Study Arms (2)

Cap Assisted Colonoscopy

Patients receiving colonoscopies where scope is fitted with cap

Standard Colonoscopy

Patients receiving standard colonoscopy without the cap on the scope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Endoscopy Clinic- Patients already receiving colonoscopies

You may qualify if:

  • Patients already booked for a colonoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

  • Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.

    PMID: 19098847RESULT

Study Officials

  • Donald G MacIntosh, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2010

First Posted

May 20, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Study was terminated

Locations

CA(1)