RecruitingNot ApplicableNCT06748352

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

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study


Sponsor

Shandong University

Enrollment

50 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a robot-assisted technique to improve a minimally invasive procedure called endoscopic submucosal dissection (ESD), which is used to remove early-stage stomach cancers or pre-cancerous lesions without open surgery. The goal is to see if the robotic traction method makes the procedure safer and more effective. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with either high-grade pre-cancerous changes or early-stage cancer limited to the inner lining of the stomach, confirmed by a tissue sample **You may NOT be eligible if...** - There is evidence or suspicion that your cancer has grown deeper into the stomach wall or spread to lymph nodes - You have serious health conditions that prevent safe use of general anesthesia or surgery - You have previously had stomach cancer surgery or radiation to the stomach area - Your lesion has recurred after a previous endoscopic removal procedure - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREFASTER-assisted ESD

The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.

PROCEDUREConventional ESD

The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06748352


Related Trials