NCT06189859 Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
| NCT ID | NCT06189859 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cairo University |
| Condition | Achalasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-03-16 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 52 participants in total. It began in 2024-03-16 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
hany shehab
PRINCIPAL INVESTIGATOR
Cairo University
Frequently Asked Questions
Who can join the NCT06189859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06189859 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 52 participants.
Is NCT06189859 currently recruiting?
Yes, NCT06189859 is actively recruiting participants. Contact the research team at h.shehab@kasralainy.edu.eg for enrollment information.
Where is the NCT06189859 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06189859 clinical trial?
NCT06189859 is sponsored by Cairo University. The principal investigator is hany shehab at Cairo University. The trial plans to enroll 52 participants.