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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073578
First Posted: February 27, 2014
Last Update Posted: September 24, 2015
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.
Information provided by (Responsible Party):
Kyle A Perry, Ohio State University
  Purpose
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
Achalasia Procedure: Peroral Endoscopic Myotomy (POEM) Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Kyle A Perry, 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
Treatment
Peroral Endoscopic Myotomy (POEM)
Procedure: Peroral Endoscopic Myotomy (POEM)
Endoscopy myotomy for treatment of achalasia

  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT02073578


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

Responsible Party: Kyle A Perry, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02073578     History of Changes
Other Study ID Numbers: 2011H0240
First Submitted: February 24, 2014
First Posted: February 27, 2014
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Kyle A Perry, Ohio State University:
achalasia
POEM
peroral endoscopic myotomy
myotomy
Heller myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases