Peroral Endoscopic Myotomy (POEM) For The Treatment Of Achalasia: A Registry
POEM Registry
1 other identifier
observational
200
1 country
1
Brief Summary
Prospective Multicenter registry study to assess the safety and efficacy of clinically indicated peroral endoscopic myotomy (POEM) for the treatment of Achalasia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
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
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFebruary 20, 2017
February 1, 2017
3.8 years
June 10, 2014
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Success
Documentation of clinical success rates such as achievement of symptoms remission (dysphagia, reflux, etc.) and reduced lower esophageal sphincter pressures (manometry).
1 year
Secondary Outcomes (1)
Safety Rate
6 months
Study Arms (1)
POEM for Achalasia
Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia.
Interventions
Eligibility Criteria
Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia and above or equal to 18 years of age
You may qualify if:
- Any patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia
- Above or equal to 18 years of age
You may not qualify if:
- Any patient who has not undergone POEM for the treatment of Achalasia
- Below 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10021, United States
Related Publications (2)
Kumta NA, Mehta S, Kedia P, Weaver K, Sharaiha RZ, Fukami N, Minami H, Casas F, Gaidhane M, Lambroza A, Kahaleh M. Peroral endoscopic myotomy: establishing a new program. Clin Endosc. 2014 Sep;47(5):389-97. doi: 10.5946/ce.2014.47.5.389. Epub 2014 Sep 30.
PMID: 25324996BACKGROUNDTyberg A, Seewald S, Sharaiha RZ, Martinez G, Desai AP, Kumta NA, Lambroza A, Sethi A, Reavis KM, DeRoche K, Gaidhane M, Talbot M, Saxena P, Zamarripa F, Barret M, Eleftheriadis N, Balassone V, Inoue H, Kahaleh M. A multicenter international registry of redo per-oral endoscopic myotomy (POEM) after failed POEM. Gastrointest Endosc. 2017 Jun;85(6):1208-1211. doi: 10.1016/j.gie.2016.10.015. Epub 2016 Oct 15.
PMID: 27756611DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Endoscopy
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 12, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
February 20, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
No IPD sharing