N/A
N=448
Third Eye Retroscope Randomized Clinical Evaluation
Colorectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01044732 ↗Enrolled (actual)
448
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Detection Rates for Adenomas and for Total Polyps — 160; 163; 78; 31 Polyps or adenomas detected
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
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rates for Adenomas and for Total Polyps |
160; 163; 78; 31; 107; 115 | — |
| SECONDARY Times for Withdrawal Phase and for Complete Procedure |
7.58; 9.52; 16.97; 20.87 | — |
Summary
The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone.
Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.
Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
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 (NCT01044732). 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.