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

Not Applicable

Completed

• Conditions: Achalasia
• Interventions: Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

• Registration Number: NCT01584635
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-25
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peroral Endoscopic Myotomy (POEM)	Peroral Endoscopic Myotomy a less invasive treatment for Achalasia	Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	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.

Secondary Outcome Measures

Name	Time	Method
Eckardt symptom score	5 years	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States