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

N/ACompletedNCT01955122

EndoAid126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

126

Conditions

Colon Cancer

Interventions

Tandem ColonoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject between the ages of 40 and 75 * The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * Written informed consent must be available before enrollment in the trial Exclusion Criteria: * Patients with a history of colonic resection; * Patients with known (or newly diagnosed) inflammatory bowel disease; * Patients with a personal history of polyposis syndrome; * Patients with suspected chronic stricture potentially precluding complete colonoscopy; * Patients with diverticulitis or toxic megacolon; * Patients with a history of radiation therapy to abdomen or pelvis; * Patients with a hemorrhagic diathesis * Patients with acute lower GI bleeding * Pregnant women and women with childbearing potential without adequate contraception * Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Locations (3)

Indiana University

Indianapolis, Indiana, United States

Elisha Medical Center

Haifa, Please Select, Israel

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Adenoma and Polyp Miss Rate

Group A- we measured the Adenoma\&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings). Group B- we measured the Adenoma\&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard). Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group\]\*100

Time frame: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.

Secondary Outcomes

Total Number of Therapeutic Interventions Performed

Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.

Time frame: Interventions during procedure

Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured

The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured

Time frame: During the procedure

Sedation

Sedation dosage

Time frame: During the procedure

Scope Centering Ability

Ability to center the scope inside the gastrointestinal tract.

Data from ClinicalTrials.gov

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