Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Achalasia Clinical Trial

— POEM  

Official title:

Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073578
• Other study ID #: 2011H0240
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Peroral Endoscopic Myotomy (POEM)
Endoscopy myotomy for treatment of achalasia

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Efficacy of POEM Procedure	To assess adverse events related to POEM	Intraoperative to one year follow-up
Primary	Long-term patient-reported quality of life	To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up.	Baseline to one year follow-up