Recruiting

Bipolar Radiofrequency Ablation

Sponsor:

Baylor College of Medicine

Code:

NCT06476678

Conditions

Esophageal Neoplasm

Esophageal Polyp

Endoscopic Submucosal Dissection

Bipolar Electrocautery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Speedboat™ Ultraslim

Study Details

Brief summary:

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Conditions

Esophageal Neoplasm

Esophageal Polyp

Endoscopic Submucosal Dissection

Bipolar Electrocautery

Study ID

NCT06476678

Start date

Oct 15, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is >18 years of age
  • Patient can provide informed consent
  • Patient is referred for resection of precancerous lesions meeting the following criteria:

  • Mucosal based polyp
  • Located gastroesophageal junction (GEJ) or proximal to GEJ
  • No previous endoscopic resection attempted (EMR or ESD)

Exclusion Criteria:

  • Patients with International Normalized Ratio (INR) >1.5 or Platelets <50,000
  • Lesions extending past GEJ
  • Subepithelial lesions

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment arm

Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD).

Interventions

Speedboat™ Ultraslim

Use of Speedboat™ Ultraslim for performing endoscopic submucosal dissection of esophageal lesions.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Salmaan A Jawaid, MD

7137980950Salmaan.Jawaid@bcm.edu

Haydee Rochits Cueto

7137983606Haydee.RochitsCueto@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Haydee Rochits Cueto

7137983606Haydee.RochitsCueto@bcm.edu

Salmaan Jawaid, MD

713-798-0950Salmaan.Jawaid@bcm.edu

Principal Investigator:

Salmaan Jawaid, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

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 2026-03-25.