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Completed

NCT Number: NCT01584635

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

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.

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Key information

Conditions

Achalasia Deglutition Disorders Digestive System Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peroral Endoscopic Myotomy a less invasive treatment for Achalasia

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Eckardt symptom score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia

Acronym: POEM

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2012
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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