Achalasia
Conditions
Keywords
achalasia, POEM, peroral endoscopic myotomy, myotomy, Heller myotomy
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.
Interventions
PROCEDUREPeroral Endoscopic Myotomy (POEM)
Endoscopy myotomy for treatment of achalasia
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed