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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
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego

July 21, 2011
July 26, 2011
October 26, 2016
November 2009
November 2019   (Final data collection date for primary outcome measure)
To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia [ Time Frame: 1 year ]
  • Pain assessment based on the Visual Analog Scale. [ Time Frame: 1 year ]
    Pain levels will be assessed using the Visual Analog Scale (VAS) at Baseline, 6 months, and 1 year.
  • Dysphagia Assessment. [ Time Frame: 1 year ]
    Dysphagia will be assessed using the Dysphagia Assessment at baseline, 6 months, and 1 year.
  • Reflux symptoms assessment using the GERD HRQL. [ Time Frame: 1 year ]
    Reflux symptoms will be assessed using the GERD HRQL at baseline, 6 months, and 1 year.
  • Quality of life assessment using the SF36. [ Time Frame: 1 year ]
    Quality of Life will be assessed at baseline, 6 months, and 1 year.
  • Safety assessment based on the # of adverse events. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01402518 on ClinicalTrials.gov Archive Site
To assess the quality of life, pain, and complications of the POEM approach [ Time Frame: 1 year ]
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Per-Oral Endoscopic Myotomy
Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
Procedure: Per-oral enodscopic myotomy
Other Name: POEM
Per-oral endoscopic myotomy
Intervention: Procedure: Per-oral enodscopic myotomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2019
November 2019   (Final data collection date for primary outcome measure)


  1. Diagnosis of achalasia
  2. Age 18-75
  3. Mentally competent to give informed consent
  4. Scheduled to undergo a POEM procedure


  1. Pregnant women
  2. Any prior surgical treatment for achalasia
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
United States
091170, 150261
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Santiago Horgan, University of California, San Diego
University of California, San Diego
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Principal Investigator: Santiago Horgan, M.D., FACS UCSD
University of California, San Diego
October 2016