Clinical trial · Interventional
Efficacy of Cap-assisted Chromoendoscopy as a Screening Test for Colorectal Neoplasm Using Web-based Research Network
Prospective Randomized Controlled Trial of Cap-Assisted ChromoEndoscopy(CapACE) Versus Conventional Colonoscopy(CC) for the Detection of Colorectal Neoplasia
NCT01112280CI-TRIAL-00036120CapACEcompletedN/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)
The investigators plan to conduct a multi-center, randomized controlled trial to investigate the efficacy of cap-assisted chromoendoscopy as a screening test for detection of colorectal polyp. This study will be performed using web-based research network, e-VELOS in Korea.
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 Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cap-assisted chromoendoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cap-assisted chromoendoscopy
- description
- To the tip of the colonoscope, transparent cap is fitted and applied. In addition, panchromoendoscopy using indigocarmine solution is preformed in this group.
- interventionNames
- Device: cap-assisted chromoendoscopy
- type
- NO_INTERVENTION
- label
- Standard colonoscopy
- description
- Neither transparent cap nor chromoendoscopy is applied in this group and standard colonoscopy is performed.
Primary outcomes (1)
- measure
- Adenoma detection rate
- timeFrame
- 7 days is needed to confirm the pathologic examination.
- description
- The proportion of subjects with at least one adenoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All asymptomatic colonoscopic examinees Exclusion Criteria: * Familial history of hereditary colorectal cancer * History of colorectal cancer * Patients had received colonoscopy examination before * Familial or past history of FAP(familiar adenomatous polyposis) * Colonic polyposis syndrome * Prior colonic resection of any part of the colon * Allergy to indigo carmine * Inflammatory bowel disease * Pregnancy * Inability to provide informed consent
References
Publications (1)
- DERIVEDKim SY, Park HJ, Kim HS, Park DI, Cha JM, Park SJ, Choi H, Shin JE, Eun CS, Kim JO, Kim HG, Kim SE, Park CH, Kim TI, Hong SN. Cap-Assisted Chromoendoscopy Using a Mounted Cap Versus Standard Colonoscopy for Adenoma Detection. Am J Gastroenterol. 2020 Mar;115(3):465-472. doi: 10.14309/ajg.0000000000000510. PMID 31972618