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Completed

NCT Number: NCT01770249

Evaluation of a Novel Endoscopic Treatment for Achalasia

This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm
  • Ability to undergo general anesthesia
  • The subject is > 18 yrs.of age
  • Ability to give informed consent

Exclusion criteria

  • o Sigmoid achalasia
  • Contraindicated for EGD
  • Pregnancy

Treatment and study plan

Per-oral Endoscopic Esophagomyotomy (POEM)

Procedure

The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.

Other names: POEM

Primary outcomes

  1. The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure

    Time frame: Within the first 3 months after surgery

    Will assess the outcomes and efficacy of the endoscopic procedure, Per-oral Endoscopic Esophagomyotomy(POEM)in the treatment of achalasia. The patient will be assessed for improvement of their swallowing as assessed on the repeat time barium swallow and increase oral intake without nausea and vomiting.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Acronym: POEM

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2013
Registry last updated
Apr 20, 2022

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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