Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
- Conditions
- Achalasia
- Registration Number
- NCT02073578
- Lead Sponsor
- Ohio State University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Diagnosis of Achalasia
- Age 16-80
- ASA Class 1-3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and Efficacy of POEM Procedure Intraoperative to one year follow-up To assess adverse events related to POEM
Long-term patient-reported quality of life Baseline to one year follow-up To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
The Ohio State University Wexner Medical Center🇺🇸Columbus, Ohio, United States