Clinical trial · Interventional
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
NCT01917513CI-TRIAL-00031317completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyps | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-EYE™ colonoscopy | Device | — | UNRESOLVED |
| Standard Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G-EYE™ colonoscopy
- description
- G-EYE™ colonoscopy
- interventionNames
- Device: G-EYE™ colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Standard Colonoscopy
- description
- Standard Colonoscopy
- interventionNames
- Device: Standard Colonoscopy
Primary outcomes (1)
- measure
- Detection Rate of Adenomas and Serrated Lesions
- timeFrame
- Approximalty following 14 days (histology results)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients over 50 years old 2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection). 3. The patient must understand and provide written consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with a history of radiation therapy to abdomen or pelvis; 6. Pregnant or lactating female subjects; 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)
References
Publications (1)
- DERIVEDShirin H, Shpak B, Epshtein J, Karstensen JG, Hoffman A, de Ridder R, Testoni PA, Ishaq S, Reddy DN, Gross SA, Neumann H, Goetz M, Abramowich D, Moshkowitz M, Mizrahi M, Vilmann P, Rey JW, Sanduleanu-Dascalescu S, Viale E, Chaudhari H, Pochapin MB, Yair M, Shnell M, Yaari S, Hendel JW, Teubner D, Bogie RMM, Notaristefano C, Simantov R, Gluck N, Israeli E, Stigaard T, Matalon S, Vilkin A, Benson A, Sloth S, Maliar A, Waizbard A, Jacob H, Thielsen P, Shachar E, Rochberger S, Hershcovici T, Plougmann JI, Braverman M, Tsvang E, Abedi AA, Brachman Y, Siersema PD, Kiesslich R. G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointest Endosc. 2019 Mar;89(3):545-553. doi: 10.1016/j.gie.2018.09.028. Epub 2018 Sep 28. PMID 30273591