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

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ClinicalTrials.gov Identifier: NCT02073578
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Primary Completion Date : September 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

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 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:
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