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NCT05272046 · ClinicalTrials.gov registry record · NA
Monopolar and Bipolar Current RFA Knife in POEM
A NA study of Esophageal Motility Disorders, sponsored by Baylor College of Medicine.
- Active
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 3
- Study locations
NCT05272046: Active NA study of Esophageal Motility Disorders, sponsored by Baylor College of Medicine.
NCT05272046 is a NA study of Esophageal Motility Disorders that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 105 participants, above the 62-participant average among 3 other Esophageal Motility Disorders trials with a reported enrollment target (69% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05272046, a NA study of Esophageal Motility Disorders, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 3
- Study locations
Study Summary
Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.
Primary Outcome
Use of a Visual Analog Scale (VAS) from 0-10 with "0" being no pain and "10" being the worse pain to assess overall pain following the POEM procedure up to 24 hours.
Conditions Studied
Interventions
- PROCEDURE Per-oral Endoscopic Myotomy
- DEVICE Speedboat (Bipolar electrocautery knife)
Study Locations (3)
Other
- Asian Institute of Gastroenterology (AIG) Hospitals - Hyderabad
- Navarra Hospital Complex - Navarra Hospital - Pamplona
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2022-02-22 |
| Est. Completion | 2025-04-01 |
| Phase | NA |
What the registry record for NCT05272046 still lists
NCT05272046 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 62-participant average among 3 other Esophageal Motility Disorders trials with a reported enrollment target (69% higher).
The record links to 1 condition, with Esophageal Motility Disorders appearing as the primary indexed condition, and to 2 interventions - of which Per-oral Endoscopic Myotomy is the first listed.
NCT05272046 reports a single indexed study location in Other, Texas.
Frequently Asked Questions
What is clinical trial NCT05272046 about?
NCT05272046 is a clinical study titled "Monopolar and Bipolar Current RFA Knife in POEM". Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using stan...
What is the current status of trial NCT05272046?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2022-02-22. Estimated completion is 2025-04-01.
What conditions does trial NCT05272046 study?
This clinical trial studies the following conditions: Esophageal Motility Disorders.
What interventions are being tested in trial NCT05272046?
The interventions under investigation include: Per-oral Endoscopic Myotomy (PROCEDURE), Speedboat (Bipolar electrocautery knife) (DEVICE).
Who is sponsoring clinical trial NCT05272046?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05272046 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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