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Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm

NCT06973083 · Shandong University · Updated 21 May 2025

What is being tested
FASTER-assisted ESD; Conventional ESD
For
Robot Surgery; Endoscopic Submucosal Dissection (ESD); Colorectal Neoplasms
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 85 years. About 104 people. The full rules are on the registry page.
Where
China
When
Starts or started 1 June 2025, ends 30 Dec 2026. Registered 15 May 2025.
Results
None posted yet.

In the researchers' words

The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety. The main questions it aims to answer are: Does the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety 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. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD…
ClinicalTrials.gov, NCT06973083

Sites

  • Qilu Hospital of Shandong UniversityJinan, Shandong, China