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

Not yet recruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

March 30, 2025

Primary Completion Date

March 30, 2026

Study Completion Date

July 20, 2026

Conditions
Gastrointestinal Neoplasms
Interventions
DEVICE

Traction Device

After circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue

Trial Locations (1)

77030

Baylor College of Medicine, Houston

All Listed Sponsors
lead

Baylor College of Medicine

OTHER

NCT06747988 - Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD | Biotech Hunter | Biotech Hunter