Clinical trial · Interventional
Monopolar and Bipolar in Esophageal ESD
Randomized Controlled Trial Comparing Outcomes of Monopolar Current Cutting Knife and Bipolar RFA Knife in Esophageal Endoscopic Submucosal Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study being withdrawn as it is re-written now as a prospective study. Please reference new study
Summary
Brief summary (as posted)
The objective of this study is to prospectively document the efficacy and clinical outcomes of Endoscopic Submucosal Dissection procedure that utilize either a novel Bipolar-Current ESD device or the standard monopolar electrocautery knife.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bipolar Electocautery | — | UNRESOLVED | — |
| Endoscopic Submucosal Dissection | — | UNRESOLVED | — |
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Polyp | Esophageal Polyp | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bipolar electrocautery knife | Device | — | UNRESOLVED |
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Monopolar Electrocautery tool
- description
- Patients randomized into this group will receive the standard of care monopolar tool for their endoscopic submucosal dissection procedure.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- type
- EXPERIMENTAL
- label
- Bipolar Electrocautery tool
- description
- Patients randomized into this group will receive the standard of care bipolar tool for their endoscopic submucosal dissection procedure.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- Device: Bipolar electrocautery knife
Primary outcomes (1)
- measure
- Speed of Endoscopic Submucosal Dissection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is ≥ 18 years old * Patient is capable of providing informed consent * Patient is referred for ESD procedure of an esophageal neoplastic lesion Exclusion Criteria: * Patient is \< 18 years old * Patient refused and/or unable to provide consent * Patient is a pregnant woman * Patients with lesions removed with other techniques besides ESD (i.e. cap EMR) or a modified ESD technique
References
Publications (0)
Data not yet available