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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402518
Other study ID # 091170, 150261
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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