Actively Recruiting
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
Led by Cairo University · Updated on 2025-05-13
52
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two electrosurgical modes used in a procedure called Peroral Endoscopic Esophageal Myotomy (POEM), which treats esophageal motility disorders such as achalasia. POEM involves creating a tunnel under the esophageal lining to cut muscle and improve swallowing. This phase 3 randomized trial compares the safety and effectiveness of Spray coagulation mode and Precisect mode during the submucosal dissection step of POEM. Participants will undergo the POEM procedure where, after an initial incision, the submucosal dissection is performed using either Spray coag mode or Precisect mode with an ERBE VIO3 generator and a Hybrid knife, supported by ERBEJET for injection. The Spray coag mode uses effect settings of 3 to 3.5, while Precisect mode uses effects of 4.5 to 5. Both methods aim to safely and efficiently dissect tissue down to 2 cm below the cardia. The study includes a double-blind design with random assignment to either mode. During the procedure, researchers will measure the speed of submucosal dissection as the primary outcome. Secondary outcomes include bleeding during the procedure, any significant bleeding events, other adverse events, total procedure duration, and the duration of endoscopic submucosal tunneling. Participants will be monitored closely for safety and effectiveness during the procedure. The study aims to provide evidence on which electrosurgical mode offers better performance and safety in POEM treatment. The trial is expected to complete by August 2025.
CONDITIONS
Brief Title
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing POEM procedure for any esophageal motility disorder
- Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy
You will not qualify if you...
- Esophageal varices
- Esophageal neoplasms
- Non-correctable coagulopathy
- Failure to provide an informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the POEM procedure
Participants undergo endoscopic submucosal dissection using either Spray coag mode or Precisect mode during the POEM procedure.
1 procedure visit
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 11562
Actively Recruiting
Research Team
H
hany Shehab, MD, FRCP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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