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Looking for volunteers

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

NCT06748352 · Shandong University · Updated 27 Dec 2024

What is being tested
FASTER-assisted ESD; Conventional ESD
For
Early Gastric Cancer; Endoscopic Submucosal Dissection; Robot Surgery
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 80 years. About 50 people. The full rules are on the registry page.
Where
China
When
Starts or started 30 Dec 2024, ends 1 March 2025. Registered 27 Dec 2024.
Results
None posted yet.

In the researchers' words

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are: Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system. Participants will: Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system. Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
ClinicalTrials.gov, NCT06748352

Sites

  • Qilu Hospital of Shandong UniversityJinan, Shandong, China