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The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01584635
First received: January 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.

The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.


Condition Intervention
Achalasia
 Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 5 years post surgery ] [ Designated as safety issue: No ]
    Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.


Secondary Outcome Measures:
  • Eckardt symptom score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peroral Endoscopic Myotomy (POEM)
Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia
 Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
Other Names:
  • Achalasia
  • Heller myotomy
  • Dysphagia
  • Peroral Endoscopic Myotomy
  • Disease of the muscle of the esophagus.
  • Disorder of the swallowing tube.
  • Esophageal Motility Disorders
  • Esophageal Achalasia

  Eligibility

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

Inclusion Criteria:

  • Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.

Exclusion Criteria:

  • Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.
  • Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:
  • The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)
  • The patient is at least one year postmenopausal (no menses for 12 months).
  • The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.
  • Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
  • Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.
  • Vulnerable populations, such as those with diminished mental acuity, will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584635

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Katzka, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01584635     History of Changes
Other Study ID Numbers: 11-005252
Study First Received: January 12, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Less invasive treatment for Achalasia

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

ClinicalTrials.gov processed this record on June 18, 2013