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Evaluation of a Novel Endoscopic Treatment for Achalasia (POEM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Ponsky, MD., F.A.C.S., University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01770249
First received: January 15, 2013
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770249

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Jeffrey Ponsky, MD., F.A.C.S., Principal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01770249     History of Changes
Other Study ID Numbers: 03-12-10
Study First Received: January 15, 2013
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
dysphagia

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

ClinicalTrials.gov processed this record on May 19, 2013