Clinical trial · Interventional
Monopolar Current Cutting Knife vs Bipolar RFA Knife
Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in Colonic Endoscopic Submucosal Dissection
NCT04919824CI-TRIAL-00106304active not recruitingN/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 is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ESD) procedure at Baylor St. Luke's Medical Center.
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 |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Mucosal Resection | Procedure | — | UNRESOLVED |
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bipolar Knife
- description
- ESD procedure performed with a novel bipolar knife.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- Procedure: Endoscopic Mucosal Resection
- type
- ACTIVE_COMPARATOR
- label
- Monopolar Knife
- description
- ESD procedure performed with monopolar knives.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- Procedure: Endoscopic Mucosal Resection
Primary outcomes (1)
- measure
- Procedure time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is ≥ 18 years old 2. Patient is capable of providing informed consent 3. Patient is referred for ESD procedure of gastrointestinal neoplastic lesions Exclusion Criteria: 1. Patient is \< 18 years old 2. Patient refused and/or unable to provide consent 3. Patient is a pregnant woman 4. Patients with lesions removed with other techniques besides ESD or a modified ESD technique (i.e., EMR or TEM) as defined in the Japan Gastroenterological Endoscopy Society (JGES) guidelines for endoscopic resection of lesions.
References
Publications (8)
- BACKGROUNDTakeuchi Y, Uedo N, Ishihara R, Iishi H, Kizu T, Inoue T, Chatani R, Hanaoka N, Taniguchi T, Kawada N, Higashino K, Shimokawa T, Tatsuta M. Efficacy of an endo-knife with a water-jet function (Flushknife) for endoscopic submucosal dissection of superficial colorectal neoplasms. Am J Gastroenterol. 2010 Feb;105(2):314-22. doi: 10.1038/ajg.2009.547. Epub 2009 Sep 22. PMID 19773749
- BACKGROUNDHong MJ, Kim JH, Lee SY, Sung IK, Park HS, Shim CS. Prevalence and clinical features of coagulation syndrome after endoscopic submucosal dissection for colorectal neoplasms. Dig Dis Sci. 2015 Jan;60(1):211-6. doi: 10.1007/s10620-014-3484-9. Epub 2014 Dec 13. PMID 25502119
- BACKGROUNDJung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29. PMID 23990482
- BACKGROUNDTsiamoulos ZP, Sebastian J, Bagla N, Hancock C, Saunders BP. A new approach to endoscopic submucosal tunneling dissection: the "Speedboat-RS2" device. Endoscopy. 2019 Jul;51(7):E185-E186. doi: 10.1055/a-0875-3352. Epub 2019 Apr 12. No abstract available. PMID 30978741
- BACKGROUNDIsmail MS, Bahdi F, Mercado MO, Habazi R, Alexander A, Prabhu S, John S, Kovvali C, Othman MO. ESD with double-balloon endoluminal intervention platform versus standard ESD for management of colon polyps. Endosc Int Open. 2020 Oct;8(10):E1273-E1279. doi: 10.1055/a-1226-6372. Epub 2020 Sep 22. PMID 33015328
- BACKGROUNDCao Y, Liao C, Tan A, Gao Y, Mo Z, Gao F. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy. 2009 Sep;41(9):751-7. doi: 10.1055/s-0029-1215053. Epub 2009 Aug 19. PMID 19693750
- BACKGROUNDShinmura K, Ikematsu H, Kojima M, Nakamura H, Osera S, Yoda Y, Hori K, Oono Y, Ochiai A, Yano T. Safety of endoscopic procedures with monopolar versus bipolar instruments in an ex vivo porcine model. BMC Gastroenterol. 2020 Jan 31;20(1):27. doi: 10.1186/s12876-020-1176-9.