Clinical trial · Interventional
Efficacy of the Third Eye Retroscope Auxiliary Imaging System
A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Third Eye Retroscope Auxiliary Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Third Eye Retroscope
- description
- Colonoscopy exam using the Third Eye Retroscope device
- interventionNames
- Device: Third Eye Retroscope Auxiliary Imaging System
Primary outcomes (2)
- measure
- Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)
- timeFrame
- Total 30 minutes procedure time with TER use.
- description
- After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
- measure
- Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 \<50 years or \>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.
References
Publications (1)
- RESULTWaye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16. PMID 20018280