Status:
COMPLETED
Endoscopic Myotomy for the Treatment of Achalasia (Motility Disorder) of the Esophagus - POEM Procedure
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Achalasia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 cut...
Detailed Description
The purpose of this research study is to find out more about a less invasive way of doing the surgical procedure (esophageal myotomy) to treat Achalasia. Achalasia is a disease of the esophagus, wher...
Eligibility Criteria
Inclusion
- Diagnosis of achalasia
- Age 18-65
- ASA class 1-2
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01873300
Start Date
February 1 2012
End Date
August 1 2014
Last Update
April 9 2015
Active Locations (1)
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1
Masschusetts General Hospital
Boston, Massachusetts, United States, 02114