Per-Oral Endoscopic Myotomy

Achalasia Clinical Trial

— POEM  

Official title:

Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402518
• Other study ID #: 091170, 150261
• Status: Completed
• Start date: November 2009
• Est. completion date: November 2019

Study information

• Verified date: April 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion:

1. Diagnosis of achalasia

2. Age 18-75

3. Mentally competent to give informed consent

4. Scheduled to undergo a POEM procedure

Exclusion:

1. Pregnant women

2. Any prior surgical treatment for achalasia

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Per-oral enodscopic myotomy

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia		1 year
Secondary	To assess the quality of life, pain, and complications of the POEM approach		1 year