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Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

This study has been completed.
Information provided by (Responsible Party):
Kyle A Perry, Ohio State University Identifier:
First received: February 24, 2014
Last updated: September 22, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Procedure: Peroral Endoscopic Myotomy (POEM)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Adverse Events related to POEM [ Time Frame: Intraoperative to one year follow-up ]
    To assess adverse events related to POEM

  • Quality of life [ Time Frame: 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. It is expected that quality of life measures will improve post-POEM.

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Peroral Endoscopic Myotomy (POEM)
Procedure: Peroral Endoscopic Myotomy (POEM)
Endoscopy myotomy for treatment of achalasia


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02073578

United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Principal Investigator: Vimal K Narula, MD Ohio State University
  More Information

Responsible Party: Kyle A Perry, Assistant Professor, Ohio State University Identifier: NCT02073578     History of Changes
Other Study ID Numbers: 2011H0240
Study First Received: February 24, 2014
Last Updated: September 22, 2015

Keywords provided by Ohio State University:
peroral endoscopic myotomy
Heller myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 28, 2017