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

Completed · Not applicable

Conditions studied: Achalasia

In brief

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.

Key facts

Study ID

NCT01584635

Run by

Mayo Clinic

People needed

20

Starts

2012-01-01

Expected to finish

2016-01-01

Last updated by the study team

2016-10-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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