Clinical trial · Interventional
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
NCT03072472CI-TRIAL-00034716B-ADENOMAcompletedN/AClinicalTrials.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)
This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.
Conditions
Conditions (14)
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 |
| Colonic Diseases | — | UNRESOLVED | — |
| Colonic Polyp | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Digestive Disease | — | UNRESOLVED | — |
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Intestinal Diseases | — | UNRESOLVED | — |
| Intestinal Neoplasms | Intestinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Intestinal Polyps | — | UNRESOLVED | — |
| Neoplasia GI | — | UNRESOLVED | — |
| Neoplasms, Glandular and Epithelial |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocuff Vision | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endocuff-assisted Flexible Sigmoidoscopy
- description
- Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
- interventionNames
- Device: Endocuff Vision
- type
- NO_INTERVENTION
- label
- Standard Flexible Sigmoidoscopy
- description
- Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope
Primary outcomes (1)
- measure
- Adenoma Detection Rate
- timeFrame
- Day of procedure
- description
- Proportion of examinations expressed as a percentage where at least one adenoma is found
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years and over 2. Referral for screening flexible sigmoidoscopy 3. Ability to give informed consent Exclusion Criteria: 1. Absolute contraindications to flexible sigmoidoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage) 6. Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal 9. Pregnancy
References
Publications (1)
- DERIVEDRees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD, Verma AM, Lee TJ, Walls M; B-ADENOMA trial group comprises. BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3. PMID 32245908