Evaluation of a Novel Endoscopic Treatment for Achalasia (POEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770249
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : June 17, 2014
Information provided by (Responsible Party):
Jeffrey Ponsky, MD., F.A.C.S., University Hospitals Cleveland Medical Center

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

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Per-oral Endoscopic Esophagomyotomy (POEM) Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Per-oral Endoscopic Esophagomyotomy (POEM)
An endoscopic surgical procedure for achalasia; Per-oral Endoscopic Esophagomyotomy (POEM)will be performed. The POEM procedure will be performed in the operating room under general anesthesia and a scope will then be inserted into your mouth and down your throat and measurements will be taken. With the use of this lighted flexible scope the surgeon will make a small incision in the inner lining of your esophagus (throat), create a tunnel and then cut the muscle between the esophagus (throat) and the stomach. The initial little opening will be closed with a small clip. This procedure will allow easier passage of food into the stomach.
Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)
The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.
Other Name: POEM

Primary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01770249

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Principal Investigator: Ponsky Jeffrey, MD University Hospitals Cleveland Medical Center

Responsible Party: Jeffrey Ponsky, MD., F.A.C.S., Principal Investigator, University Hospitals Cleveland Medical Center Identifier: NCT01770249     History of Changes
Other Study ID Numbers: 03-12-10
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

Keywords provided by Jeffrey Ponsky, MD., F.A.C.S., University Hospitals Cleveland Medical Center:

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases