Comparing electrosurgical techniques for treating achalasia
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
PHASE3 · Cairo University · NCT06189859
This study is testing two different electrosurgical techniques during a procedure for achalasia to see which one works better and causes less tissue damage.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06189859 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of two electrosurgical modes, Spray Coagulation and Precisect mode, during the Peroral Endoscopic Esophageal Myotomy (POEM) procedure for patients with achalasia. The study aims to determine which mode provides better outcomes in terms of tissue damage and coagulation efficiency. Participants will undergo high-resolution manometry and gastroscopy to confirm their esophageal motility disorder before being assigned to one of the two intervention groups.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with esophageal motility disorders who are scheduled for a POEM procedure.
Not a fit: Patients with esophageal varices, neoplasms, or non-correctable coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and efficacy in the treatment of achalasia, enhancing patient outcomes.
How similar studies have performed: While there have been studies on electrosurgical techniques, this specific comparison of Spray Coagulation and Precisect mode in POEM is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: hany shehab — Cairo University
- Study coordinator: hany Shehab, MD, FRCP
- Email: h.shehab@kasralainy.edu.eg
- Phone: +201111111071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Achalasia, Achalasia Cardia, achalasia, POEM, ELECTROSURGERY, SPRAY COAGULATION, PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY