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Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders

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.
 
ClinicalTrials.gov Identifier: NCT01524471
Recruitment Status : Unknown
Verified January 2012 by Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : February 2, 2012
Last Update Posted : February 2, 2012
Sponsor:
Information provided by:
Chinese University of Hong Kong

Brief Summary:
Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Per Oral Endoscopic Myotomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : July 2010
Estimated Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: POEM
Endoscopic Myotomy
Procedure: Per Oral Endoscopic Myotomy



Primary Outcome Measures :
  1. Dysphagia score

Secondary Outcome Measures :
  1. Improvement in LES pressure
  2. Eckhart score
  3. Operative time
  4. Length of myotomy
  5. Time to resume diet
  6. Morbidities


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

  • Patients will be excluded from this study with the followings -

    1. Pregnancy
    2. Informed consent not available
    3. Previous history of esophagectomy or mediastinal surgery
    4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
    5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM

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 ClinicalTrials.gov identifier (NCT number): NCT01524471


Contacts
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Contact: Philip WY Chiu, MD 26322627 philipchiu@surgery.cuhk.edu.hk

Locations
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Hong Kong
Department of Surgery, Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong, 00000
Contact: Philip WY Chiu, MD    26322627    philipchiu@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
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ClinicalTrials.gov Identifier: NCT01524471    
Other Study ID Numbers: CRE_2010.430
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Chinese University of Hong Kong:
Hypertensive LES
Additional relevant MeSH terms:
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Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases