N/A
N=328
Impact of Experience on Results With the Third Eye Retroscope
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00969124 ↗Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Detection Rates for Adenomas — 100; 16 Adenomas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Third Eye Retroscope (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Avantis Medical Systems
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rates for Adenomas |
100; 16 | — |
| PRIMARY Detection Rates for All Polyps |
182; 27 | — |
| SECONDARY Time Spent During Withdrawal Phase and Total Procedure |
9.9; 24.7 | — |
Summary
The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope.
Previous studies have shown that physicians are able to detect additional polyps when they use the device along with the colonoscope. The purpose of this study is to determine whether physicians can detect greater numbers of additional polyps as they gain in experience with the device.
Eligibility Criteria
Inclusion Criteria
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- The patient must understand and provide written consent for the procedure.
Exclusion Criteria
- Patients with a history of colonic resection;
- Patients with 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 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 (NCT00969124). 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.