Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 126
- Locations
- 5
- Primary Endpoint
- Adenoma and Polyp Miss Rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Adenoma and Polyp Miss Rate
Time Frame: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.
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
Secondary Outcomes
- Sedation(During the procedure)
- Colon Area Screened(During the 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(During the procedure)
- Total Number of Therapeutic Interventions Performed(Interventions during procedure)
- Scope Centering Ability(During the procedure)
- Patient Satisfaction(24 hours post procedure)