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Per-Oral Endoscopic Myotomy (POEM)

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ClinicalTrials.gov Identifier: NCT01402518
Recruitment Status : Recruiting
First Posted : July 26, 2011
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Per-oral enodscopic myotomy Phase 1

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure
Study Start Date : November 2009
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Per-oral endoscopic myotomy Procedure: Per-oral enodscopic myotomy
Other Name: POEM


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To assess the quality of life, pain, and complications of the POEM approach [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402518


Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, M.D., FACS         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, M.D., FACS UCSD
More Information

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01402518     History of Changes
Other Study ID Numbers: 091170, 150261
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Santiago Horgan, University of California, San Diego:
achalasia
myotomy
endoscopic myotomy
difficulty swallowing

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases