This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Evaluation of a Novel Endoscopic Treatment for Achalasia (POEM)

This study has been completed.
Information provided by (Responsible Party):
Jeffrey Ponsky, MD., F.A.C.S., University Hospitals of Cleveland Identifier:
First received: January 15, 2013
Last updated: June 16, 2014
Last verified: June 2014
This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

Condition Intervention
Achalasia Procedure: Per-oral Endoscopic Esophagomyotomy (POEM)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Resource links provided by NLM:

Further study details as provided by Jeffrey Ponsky, MD., F.A.C.S., University Hospitals of Cleveland:

Primary Outcome Measures:
  • 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.

Enrollment: 10
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Jeffrey Ponsky, MD., F.A.C.S., Principal Investigator, University Hospitals of Cleveland Identifier: NCT01770249     History of Changes
Other Study ID Numbers: 03-12-10
Study First Received: January 15, 2013
Last Updated: June 16, 2014

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

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 21, 2017