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Per-Oral Endoscopic Myotomy (POEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402518
First received: July 21, 2011
Last updated: October 24, 2016
Last verified: October 2016

July 21, 2011
October 24, 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 ] [ Designated as safety issue: No ]
  • Pain assessment based on the Visual Analog Scale. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pain levels will be assessed using the Visual Analog Scale (VAS) at Baseline, 6 months, and 1 year.
  • Dysphagia Assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.
Achalasia
Procedure: Per-oral enodscopic myotomy
Other Name: POEM
Per-oral endoscopic myotomy
Intervention: Procedure: Per-oral enodscopic myotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2019
November 2019   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
United States
 
NCT01402518
091170, 150261
No
Not Provided
Not Provided
Santiago Horgan, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, M.D., FACS UCSD
University of California, San Diego
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP