Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD

Launched by BAYLOR COLLEGE OF MEDICINE · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the TTS helix tack suture, which is designed to help during a procedure known as endoscopic submucosal dissection (ESD). ESD is a method used to remove abnormal growths in the digestive tract, such as tumors. The researchers at Baylor St. Luke's Medical Center want to see if using this device can make the procedure safer and less traumatic compared to other methods.

To participate in the trial, you need to be at least 18 years old and able to give your consent. Eligible patients are those who require ESD for certain types of growths in the colon or stomach, especially if previous attempts to remove them have failed or if the growths are larger than a certain size. The trial is not currently recruiting participants, but if you join, you can expect to undergo the ESD procedure using this new device, and your progress will be monitored. It's an exciting opportunity to be part of research that could improve treatment for gastrointestinal conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient is ≥ 18 years old.
• • 2. Patients can provide informed consent.
• 3. The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria:
• • A- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions.
• Exclusion Criteria:
• • 1. The patient is \< 18 years old.
• • 2. The patient refuses and/or is unable to provide consent.
• • 3. The patient is a pregnant woman.
• • 4. Lesions with morphology: pedunculated type (Paris Ip, Ips).
• • 5. Appendiceal orifice or IC valve lesions
• • 6. Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique \[STER\] or EMR).