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: Gastrointestinal Neoplasm
Eligibility Criteria
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.
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.