Clinical trial · Interventional
EndoMaster EASE System for Treatment of Colorectal Lesions
Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
NCT04196062CI-TRIAL-00071126MASTERCESDcompletedN/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, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.
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 |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoMASTER EASE Robotic system for ESD | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic ESD
- description
- Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system
- interventionNames
- Device: EndoMASTER EASE Robotic system for ESD
Primary outcomes (1)
- measure
- Complete (R0) resection
- timeFrame
- 30 days
- description
- rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
Secondary outcomes (15)
- measure
- Bleeding during or after the procedure
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 and ≤ 85; 2. Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas. Exclusion Criteria: 1. Informed consent not available; 2. Carcinoma of colon or rectum with known involvement beyond the submucosa; 3. Evidence of distant spread of colon cancer; 4. Presence of another active malignancy; 5. Pregnancy; 6. Patients considered unfit for general anaesthesia; 7. The endoscopic platform cannot reach the target site; 8. Current participation in another clinical research study.
References
Publications (0)
Data not yet available
No reference posted for this study.