Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01601431
First received: May 14, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.


Condition Intervention
Adenoma
Device: Cap Assisted Colonoscopy
Device: Conventional colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • ADR differences in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polyp detection rate in Hispanic patients undergoing a screening colonoscopy with and without cap. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cecal intubation rate and time in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Complication rate in standard colonoscopy vs. cap assisted colonoscopy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 440
Study Start Date: April 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cap Assisted Colonoscopy Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Active Comparator: Conventional colonoscopy Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Device: Conventional colonoscopy
Regular colonoscopy as per standard clinical guidelines

Detailed Description:

This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

  1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
  2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
  3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
  4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria:

  1. Patients younger than 18 yrs old or older than 80 yrs.
  2. Patients with a prior history of colonic surgeries
  3. Patient with Crohns colitis or ulcerative colitis.
  4. Patient with prior history of colon cancer
  5. Patient with poor bowel preparation
  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: NCT01601431

Locations
United States, Texas
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01601431     History of Changes
Other Study ID Numbers: E12050
Study First Received: May 14, 2012
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Screening colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 24, 2014