Recruiting

Traction vs. No Traction

Sponsor:

Baylor College of Medicine

Code:

NCT06159634

Conditions

Gastrointestinal Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Submucosal Dissection

Traction Device

Study Details

Brief summary:

The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD.

The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Conditions

Gastrointestinal Neoplasm

Study ID

NCT06159634

Start date

Dec 5, 2023

Status verified date

Feb, 2026

Completion date

Feb 20, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient is ≥ 18 years old.
2. Patients can provide informed consent.
3. Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:

A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Exclusion Criteria:

1. Patient is < 18 years old.
2. Patient refused and/or unable to provide consent.
3. 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 (like hybrid ESD or submucosal tunneling technique STER and EMR).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ESD with traction device

ESD of target lesion will be performed with the assistance of a traction device.

active comparator: Control arm

ESD of target lesion will be performed without the use of a traction device

Interventions

Endoscopic Submucosal Dissection

Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.

Traction Device

Use of traction device to aid in removing target lesions

Primary outcome measure

  • Dissection speed [ Time Frame: Day 1 (procedure day) ]

Central Contacts and Locations

Central contacts

Mai Khalaf, MD

713-798-6696Mai.Khalaf@bcm.edu

Michael Mercado, BS

713-798-3606Michael.Mercado@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Mohamed O. Othman, MD

713-798-0950Mohamed.Othman@bcm.edu

Baylor St. Lukes Medical Center (BSLMC)

Recruiting

Houston, Texas, United States, 77030

Contacts

Mohamed O. Othman, MD

713-798-0950Mohamed.Othman@bcm.edu

Michael Mercado

7137983606Michael.Mercado@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 24, 2026

Last verified

Feb, 2026

Keywords

  • Endoscopic Submucosal Dissection
  • Endoscopic Traction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-24.