The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Adenoma Clinical Trial

Official title:

The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01601431
• Other study ID #: E12050
• Status: Terminated
• Phase: N/A
• Start date: March 29, 2012
• Est. completion date: February 2, 2015

Study information

• Verified date: May 2018
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 440
• Est. completion date: February 2, 2015
• Est. primary completion date: February 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma

Intervention

Device:
• Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
• Conventional colonoscopy
Regular colonoscopy as per standard clinical guidelines

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center at El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.	1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.	1 year