Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
Launched by SHANDONG UNIVERSITY · Dec 21, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new robotic system called the FASTER system to see if it can make a procedure called endoscopic submucosal dissection (ESD) safer and more efficient for patients with early gastric cancer. ESD is a procedure used to remove cancerous tissue from the stomach, and researchers want to find out if using the FASTER system can help reduce injuries to muscles during the procedure and shorten the time it takes to perform the surgery. Participants in the trial will be randomly assigned to either have the traditional ESD or the ESD assisted by the FASTER system, and they will also keep a diary to track any symptoms they experience after the procedure.
To be eligible for this trial, participants must be between 18 and 80 years old and have a specific type of stomach condition called high-grade intraepithelial neoplasia or intramucosal carcinoma. However, individuals with certain health issues, previous stomach cancer treatments, or specific types of lesions are not eligible. Those who join the trial can help researchers learn more about how to improve ESD procedures, potentially benefiting future patients with early gastric cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged 18-80.
- • Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.
- Exclusion Criteria:
- • Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
- • Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
- • Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
- • Patients have lesions with local recurrence after endoscopic resection.
- • Patients unable to obtain informed consent.
About Shandong University
Shandong University is a prestigious research institution located in Jinan, China, renowned for its commitment to advancing medical and scientific knowledge through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment conducive to groundbreaking studies that address critical healthcare challenges. Shandong University actively engages in clinical research to evaluate new therapies and interventions, contributing to the global body of medical literature and enhancing patient care. Its dedicated team of researchers and clinicians ensures adherence to the highest ethical standards and regulatory compliance, positioning the university as a key player in the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jinan, Shandong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported