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NCT06476678 · ClinicalTrials.gov registry record
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
A clinical trial of Esophageal Neoplasm and Endoscopic Submucosal Dissection, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT06476678: Recruiting study of Esophageal Neoplasm and Endoscopic Submucosal Dissection, sponsored by Baylor College of Medicine.
NCT06476678 is a study of Esophageal Neoplasm and Endoscopic Submucosal Dissection that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 50 participants, below the 958-participant average among 3 other Esophageal Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06476678, a study of Esophageal Neoplasm and Endoscopic Submucosal Dissection, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Defined as the ability to perform the entire dissection (procedure) with the novel bipolar knife
Conditions Studied
Interventions
- DEVICE Speedboat™ Ultraslim
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-10-15 |
| Est. Completion | 2025-12-31 |
What NCT06476678 shows while recruiting
NCT06476678 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 958-participant average among 3 other Esophageal Neoplasm trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Esophageal Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Speedboat™ Ultraslim is the first listed.
NCT06476678 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06476678 about?
NCT06476678 is a clinical study titled "Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions". 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 ...
What is the current status of trial NCT06476678?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2024-10-15. Estimated completion is 2025-12-31.
What conditions does trial NCT06476678 study?
This clinical trial studies the following conditions: Esophageal Neoplasm, Endoscopic Submucosal Dissection, Esophageal Polyp, Bipolar Electrocautery.
What interventions are being tested in trial NCT06476678?
The interventions under investigation include: Speedboat™ Ultraslim (DEVICE).
Who is sponsoring clinical trial NCT06476678?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06476678 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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