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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06747988
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Traction Device — 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

Study Details

The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.

Key Dates

Start date
Mar 30, 2025
Status verified
Dec 2024
Primary completion
Mar 30, 2026
Completion
Jul 20, 2026

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Technical success [ Time Frame: Day 1 (procedure day) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Mai Khalaf, MD
[email protected]
713-798-6696
Michael Mercado
[email protected]
713-798-3606
Salmaan Jawaid, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Baylor College of Medicine· Houston, TX

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