NCT01955122

Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: EndoAid · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy. To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.

Detailed description

Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures. Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy. Results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results. Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance. Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DEVICE	Tandem Colonoscopy	Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-10-07
• Last updated: 2017-03-06
• Results posted: 2017-03-06

Locations

3 sites across 3 countries: United States, Israel, Netherlands