High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

Healthy Clinical Trial

Official title:

High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398447
• Other study ID #: 17-01451
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to show Endocuff Vision could improve insertion because during loop withdrawal the cuff tends to stabilize the position of the tip, preventing its backward movement and speeding loop removal. Similarly, during inspection the main goal is to evaluate the proximal sides of folds and flexures. The process is made easier and quicker by the device. Third, during polypectomy, Endocuff Vision helps to stabilize the position and the scope tip.

Description:

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of two arms, i.e High Definition colonoscopy or High Definition colonoscopy with Endocuff Vision.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

Inclusion Criteria:

• Referral for screening or surveillance colonoscopy

• Ability to provide informed consent

Exclusion Criteria:

• Prior history of colon cancer

• History of inflammatory bowel disease

• Prior surgical resection of any part of the colon

• Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure

• History of polyposis syndrome or HNPCC

• Inability to give informed consent

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• High Definition colonoscopy
Colonoscopy without EndoCuffVision

Diagnostic Test:
• High Definition colonoscopy with Endocuff Vision
Endocuff Vision is an FDA approved device that fits over the end of a colonoscope and has flexible soft fingers that project from the sides. These fingers can be used to pull back the folds in the colon and expose mucosa on the proximal sides.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Insertion Time		1 Day
Primary	Measure of Inspection time		1 Day
Primary	Total Procedure time		1 Day