Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02073578
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : September 24, 2015
Information provided by (Responsible Party):
Kyle A Perry, 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.

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Peroral Endoscopic Myotomy (POEM) Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Study Start Date : August 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Peroral Endoscopic Myotomy (POEM)
Procedure: Peroral Endoscopic Myotomy (POEM)
Endoscopy myotomy for treatment of achalasia

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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02073578

Layout table for location information
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Layout table for investigator information
Principal Investigator: Vimal K Narula, MD Ohio State University
Layout table for additonal information
Responsible Party: Kyle A Perry, Assistant Professor, Ohio State University Identifier: NCT02073578    
Other Study ID Numbers: 2011H0240
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by Kyle A Perry, Ohio State University:
peroral endoscopic myotomy
Heller myotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases