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Procedure

peroral endoscopic myotomy (POEM) for Achalasia (POEM Trial)

N/A
Waitlist Available
Led By Dennis Hong, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-6 months
Awards & highlights
No Placebo-Only Group

Summary

This study evaluates the feasibility of endoscopic myotomy for achalasia. In achalasia, there is loss of relaxation of the lower esophageal sphincter (LES), as well as a higher baseline pressure in the LES. The most widespread treatment for this disease and the one that has the best long term results involves cutting the muscle layers of the lower esophagus and on the neighbouring stomach without injurying the underlying mucosa or inner layer of the esophageal wall. This is done during a surgery through the abdomen either with a big incision or more recently with the keyhole technique. This surgery has various potential complications, one of which being making a hole through the mucosa or not extending the cut on the muscle long enough to obtain adequate relaxation of the sphincter. The per oral endoscopic myotomy (POEM) is a new intervention that is done also under general anesthesia in the operating room; however, it involves no skin incisions and all the procedure is done through a fiber optic camera. It involves making a cut in the inner layer of the esophagus and then with cautery cut the muscle fibers responsible of the blockage and finally closing the initial opening with clips. In this study we will investigate the feasibility of this intervention both from a technical aspect as well as a logistical perspective given the local operating room constraints.

Eligible Conditions
  • Achalasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
feasibility of the POEM procedure in achalasia
Secondary study objectives
complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: peroral endoscopic myotomy (POEM)Experimental Treatment1 Intervention
The Procedure: per oral endoscopic myotomy (POEM)will be performed on all patients in this single arm study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Procedure: Per Oral Endoscopic Myotomy (POEM)
2012
N/A
~10

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
914 Previous Clinical Trials
2,615,047 Total Patients Enrolled
Dennis Hong, MDPrincipal InvestigatorSt. Josephs' Healthcare Hamilton
2 Previous Clinical Trials
60 Total Patients Enrolled
~1 spots leftby Oct 2025