N/A
N=288
Efficacy of the Third Eye Retroscope Auxiliary Imaging System
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00657371 ↗Enrolled (actual)
288
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) — 13.2 percent of polyps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Third Eye Retroscope Auxiliary Imaging System (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) |
13.2 | — |
| PRIMARY Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) |
257; 34 | — |
| SECONDARY Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used. |
— | — |
Summary
The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system.
The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps.
Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.
Eligibility Criteria
Inclusion Criteria
- The patient is undergoing colonoscopy for screening purposes or for surveillance in follow-up for previous polypectomy.
- The patient is at satisfactory risk for abdominal surgery.
- The patient must understand and provide written consent for the procedure.
Exclusion Criteria
- Patients who are 80 years of age
- Patients who are pregnant.
- Patients with history of colonic resection.
- Patients requiring ongoing anticoagulation therapy.
- Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
- Patients with hypersensitivity to opioid analgesics.
- Patients with an active systemic infection.
- Patients with suspected chronic stricture potentially precluding complete colonoscopy.
- Patients with major psychiatric disease (dementia, schizophrenia or depression).
- Patients with diverticulitis or toxic megacolon.
- Patients with 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 (NCT00657371). 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.