Per-Oral Endoscopic Myotomy (POEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 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: March 26, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Achalasia
Procedure: Per-oral enodscopic myotomy
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To assess the quality of life, pain, and complications of the POEM approach [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Per-oral endoscopic myotomy Procedure: Per-oral enodscopic myotomy
Other Name: POEM

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 21, 2011
Last Updated: March 26, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2015