Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyle A Perry, Ohio State University
ClinicalTrials.gov Identifier:
NCT02073578
First received: February 24, 2014
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

This is a pilot study for a new endoscopic treatment of achalasia. Up to 25 patients will be recruited for this trial, with the intent to treat 20 patients.


Condition Intervention Phase
Achalasia
Procedure: Peroral Endoscopic Myotomy (POEM)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Adverse Events related to POEM [ Time Frame: Intraoperative to one year follow-up ] [ Designated as safety issue: Yes ]
    To assess adverse events related to POEM

  • Quality of life [ Time Frame: Baseline to one year follow-up ] [ Designated as safety issue: No ]
    To assess change in quality of life from baseline, based on validated quality of life measures, at baseline through 1 year follow-up. It is expected that quality of life measures will improve post-POEM.


Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Peroral Endoscopic Myotomy (POEM)
    Endoscopy myotomy for treatment of achalasia
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Achalasia
  • Age 16-80
  • ASA Class 1-3

Exclusion Criteria:

  • Pregnancy
  • Any prior surgical or endoscopic treatment for achalasia -- first eight subjects.

After eight subjects have been treated as part of this study, this exclusion criteria no longer applies

  • Patients who are taking immunosuppressive medications or are immunocompromised
  • Patients on anticoagulant medications or abnormal coagulation tests
  • Patients with severe medical comorbidities, in the judgment of the treating surgeon
  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: NCT02073578

Locations
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Vimal K Narula, MD Ohio State University
  More Information

No publications provided

Responsible Party: Kyle A Perry, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02073578     History of Changes
Other Study ID Numbers: 2011H0240
Study First Received: February 24, 2014
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
achalasia
POEM
peroral endoscopic myotomy
myotomy
Heller myotomy

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

ClinicalTrials.gov processed this record on October 02, 2014