N/A
N=126
Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01955122 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Adenoma and Polyp Miss Rate — 48.3; 10.4; 52.8; 9.1 percentage of :Adenomas/Polyp missed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tandem Colonoscopy (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- EndoAid
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenoma and Polyp Miss Rate |
48.3; 10.4; 52.8; 9.1 | — |
| SECONDARY Total Number of Therapeutic Interventions Performed |
106; 121 | — |
| SECONDARY 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 |
21.6; 18.5; 9.3; 8.4; 7.4; 7.2 | — |
| SECONDARY Sedation |
— | — |
| SECONDARY Scope Centering Ability |
— | — |
| SECONDARY Colon Area Screened |
— | — |
| SECONDARY Patient Satisfaction |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01955122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.