NCT01524471

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

February 1, 2012

Last Update Submit

February 1, 2012

Conditions

Achalasia

Keywords

Hypertensive LES

Outcome Measures

Primary Outcomes (1)

  • Dysphagia score

Secondary Outcomes (6)

  • Improvement in LES pressure

  • Eckhart score

  • Operative time

  • Length of myotomy

  • Time to resume diet

  • +1 more secondary outcomes

Study Arms (1)

POEM

EXPERIMENTAL

Endoscopic Myotomy

Procedure: Per Oral Endoscopic Myotomy

Interventions

Per Oral Endoscopic MyotomyPROCEDURE
POEM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Chinese University of Hong Kong

Hong Kong, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Philip WY Chiu, MD

CONTACT

26322627philipchiu@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 2, 2012

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

HK(1)