Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia

Mayo Clinic1 site in 1 country20 target enrollmentJanuary 2012

ConditionsAchalasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Achalasia
Sponsor: Mayo Clinic
Enrollment: 20
Locations: 1
Primary Endpoint: Number of participants with adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

David A. Katzka

Principal Investigator

Mayo Clinic

Eligibility 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.

Outcomes

Primary Outcomes

Number of participants with adverse events

Time Frame: 5 years post surgery

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.