Clinical trial · Interventional
Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)
NCT06726798CI-TRIAL-00083532not yet 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 trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.
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 Neoplasm | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic submucosal dissection with EndoRobotics traction device | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic ESD arm
- interventionNames
- Procedure: Endoscopic submucosal dissection with EndoRobotics traction device
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- 30 days
- description
- Rate of complete en bloc, one-piece resection with histologically-confirmed tumour-free lateral and vertical margins
Secondary outcomes (6)
- measure
- Rate of procedural haemorrhage
- timeFrame
- 30 days
- description
- Hemorrhage at the resection site that requires transfusion, discontinuation of the procedure, or adjunctive open surgical control of haemorrhage, subcategorized by: Bleeding during the index procedure, or bleeding that occurs after the subject has left the procedure room after the index procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with endoscopic diagnosis of early gastric or colorectal neoplasia * Patients will be recruited according to ESGE and JGES guidelines for gastric \& colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection. Exclusion Criteria: * Informed consent not available * Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond * Evidence of distant metastasis * Presence of another active malignancy * Pregnancy * Patients unfit for general anesthesia * Endoscopic platform cannot reach target lesion * Patients recruited into another clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.