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Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

NCT06476678 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

DEVICE

Speedboat™ Ultraslim

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

Sponsors & Collaborators

  • Creo Medical Limited

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2027-06-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476678 on ClinicalTrials.gov