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Clinical Trials/NCT01524471
NCT01524471UnknownPhase 2

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

Chinese University of Hong Kong2 sites in 1 country20 target enrollmentStarted: July 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
20
Locations
2
Primary Endpoint
Dysphagia score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Dysphagia score

Secondary Outcomes

  • Improvement in LES pressure
  • Eckhart score
  • Operative time
  • Length of myotomy
  • Time to resume diet
  • Morbidities

Investigators

Sponsor Class
Other

Study Sites (2)

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Per-Oral Endoscopic Myotomy (P.O.E.M.) for... | Clinical Trial