Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06476678
Status
Recruiting
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Conditions

  • Bipolar Electrocautery
  • Endoscopic Submucosal Dissection
  • Esophageal Neoplasm
  • Esophageal Polyp

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Haydee Rochits Cueto
[email protected]
7137983606
Salmaan Jawaid, MD
[email protected]
713-798-0950
Salmaan Jawaid, MD (PRINCIPAL_INVESTIGATOR)
Mohamed Othman, MD (SUB_INVESTIGATOR)
Tara Keihanian, MD (SUB_INVESTIGATOR)

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By research site
Baylor College of Medicine· Houston, TX

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