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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06189859
Other study ID # ESRCT
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 16, 2024
Est. completion date August 2025

Study information

Verified date March 2024
Source Cairo University
Contact hany Shehab, MD, FRCP
Phone +201111111071
Email h.shehab@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date August 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing POEM procedure for any esophageal motility disorder - Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy Exclusion Criteria: - Esophageal varices - Esophageal neoplasms - Non-correctable coagulopathy - Failure to provide an informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speed of endoscopic submucosal dissection Speed of dissection (cm/minute) during the procedure
Secondary Intraprocedural Bleeding Bleeding necessitating change in electrosurgical mode during the procedure
Secondary Significant Intraprocedural bleeding Bleeding necessitating change of instrument to coagulating forceps during the procedure
Secondary Other Adverse events Including mucosal injury, postoperative pain, postoperative bleeding and other complications during the procedure
Secondary Total procedure duration Total procedure duration during the procedure
Secondary Endoscopic submucosal tunneling duration Endoscopic submucosal tunneling duration during the procedure
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