Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

N/ACompletedNCT02073578

Ohio State University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Achalasia

Interventions

Peroral Endoscopic Myotomy (POEM)PROCEDURE

Endoscopy myotomy for treatment of achalasia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Safety and Efficacy of POEM Procedure

To assess adverse events related to POEM

Time frame: Intraoperative to one year follow-up

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.

Time frame: Baseline to one year follow-up

Data from ClinicalTrials.gov

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