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Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

NCT06189859 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-05-13

No results posted yet for this study

Summary

Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.

Conditions

  • Achalasia
  • Achalasia Cardia

Interventions

PROCEDURE

endoscopic submucosal dissection using SPRAY COAG mode

After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Spray coag mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection

PROCEDURE

endoscopic submucosal dissection using Precisect mode

After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Precisect mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • hany shehab · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-16
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • Egypt

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 NCT06189859 on ClinicalTrials.gov