Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Not Applicable

Completed

• Conditions: Achalasia
• Interventions: Procedure: Peroral Endoscopic Myotomy (POEM)

• Registration Number: NCT02073578
• Lead Sponsor: Ohio State University

Brief Summary

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.

Detailed Description

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat or attempt to treat 20 patients. Patients for whom a POEM has been attempted but not completed (conversion to open or laparoscopic surgery, POEM surgery aborted and not re-attempted). Patients who proceed to study treatment will undergo ten years of follow-up as part of this study.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Achalasia
• Age 16-80
• ASA Class 1-3

Exclusion Criteria

• Pregnancy
• Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

• Patients who are taking immunosuppressive medications or are immunocompromised
• Patients on anticoagulant medications or abnormal coagulation tests
• Patients with severe medical comorbidities, in the judgment of the treating surgeon

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Peroral Endoscopic Myotomy (POEM)	Peroral Endoscopic Myotomy (POEM)

Primary Outcome Measures

Name	Time	Method
Long-term patient-reported quality of life	Baseline to one year follow-up	To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
Safety and Efficacy of POEM Procedure	Intraoperative to one year follow-up	To assess adverse events related to POEM

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States