Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure

Completed · Phase 1/Phase 2

Conditions studied: Achalasia

In brief

Endoscopic Esophageal Myotomy (POEM), the research procedure, splits the lower esophageal sphincter muscle fibers from the inside of the esophagus, avoiding several abdominal incisions (belly area cuts), by using an endoscope to create a small cut at the most inner layer of the esophagus to expose the esophageal sphincter muscle fibers from the inside of the esophagus. The investigators are studying whether subjects who undergo Endoscopic Esophageal Myotomy will have similar functional outcome, and at the same time less pain, scar formation and wound infection than with laparoscopic or open surgery.

Key facts

Study ID

NCT01873300

Run by

Massachusetts General Hospital

People needed

5

Starts

2012-02-01

Expected to finish

2014-08-01

Last updated by the study team

2015-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of achalasia
• Age 18-65
• ASA class 1-2

You may not qualify if…

• Pregnant women
• Any prior surgical or endoscopic treatment for achalasia except dilation less than 20 mm
• Patients who are taking immunosuppressive medications or are immunocompromised Patients on blood thinners or aspirin or with history of bleeding disorders
• ASA class III patients

Where it is running

• Masschusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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