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Completed

NCT Number: NCT02073578

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peroral Endoscopic Myotomy (POEM)

Procedure

Endoscopy myotomy for treatment of achalasia

Primary outcomes

  1. Safety and Efficacy of POEM Procedure

    Time frame: Intraoperative to one year follow-up

    To assess adverse events related to POEM

  2. Long-term patient-reported 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: POEM

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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