Clinical trial · Interventional
Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study
NCT01955122CI-TRIAL-00026290completedN/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)
To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy. To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tandem Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group A
- description
- Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.
- interventionNames
- Device: Tandem Colonoscopy
- type
- OTHER
- label
- Group B
- description
- Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.
- interventionNames
- Device: Tandem Colonoscopy
Primary outcomes (1)
- measure
- Adenoma and Polyp Miss Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subject between the ages of 40 and 75 * The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * Written informed consent must be available before enrollment in the trial Exclusion Criteria: * Patients with a history of colonic resection; * Patients with known (or newly diagnosed) 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 with a hemorrhagic diathesis * Patients with acute lower GI bleeding * Pregnant women and women with childbearing potential without adequate contraception * 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)
- DERIVEDDik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28. PMID 26220283