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

Primary Purpose

Achalasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peroral Endoscopic Myotomy (POEM)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Peroral Endoscopic Myotomy (POEM)

Outcomes

Primary Outcome Measures

Safety and Efficacy of POEM Procedure
To assess adverse events related to POEM
Long-term patient-reported quality of life
To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
September 21, 2021
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02073578
Brief Title
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Acronym
POEM
Official Title
Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Peroral Endoscopic Myotomy (POEM)
Intervention Type
Procedure
Intervention Name(s)
Peroral Endoscopic Myotomy (POEM)
Intervention Description
Endoscopy myotomy for treatment of achalasia
Primary Outcome Measure Information:
Title
Safety and Efficacy of POEM Procedure
Description
To assess adverse events related to POEM
Time Frame
Intraoperative to one year follow-up
Title
Long-term patient-reported quality of life
Description
To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
Time Frame
Baseline to one year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle M Perry, MD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

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Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

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