Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

The Ohio State University

Status: Completed

Conditions: Achalasia

Treatments: Procedure: Peroral Endoscopic Myotomy (POEM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02073578

2011H0240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Other group

Description:

Peroral Endoscopic Myotomy (POEM)

Treatment:

Procedure: Peroral Endoscopic Myotomy (POEM)