Per-Oral Endoscopic Myotomy

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.

Completed

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

Diagnosis of achalasia
Age 18-75
Mentally competent to give informed consent
Scheduled to undergo a POEM procedure

Exclusion:

Pregnant women
Any prior surgical treatment for achalasia

Treatment and study plan

Per-oral enodscopic myotomy

Procedure

Other names: POEM

Primary outcomes

To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia

Time frame: 1 year

Secondary outcomes

To assess the quality of life, pain, and complications of the POEM approach

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Acronym: POEM

Important dates

Study start: 2009
Primary completion: 2019
Study completion: 2019
First posted: Jul 26, 2011
Registry last updated: Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed