Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

NCT ID: NCT02073578

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Achalasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Peroral Endoscopic Myotomy (POEM)

Group Type OTHER

Peroral Endoscopic Myotomy (POEM)

Intervention Type PROCEDURE

Endoscopy myotomy for treatment of achalasia

Interventions

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Peroral Endoscopic Myotomy (POEM)

Endoscopy myotomy for treatment of achalasia

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Kyle A Perry

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyle M Perry, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2011H0240

Identifier Type: -

Identifier Source: org_study_id

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