Peroral Endoscopic Myotomy for the Treatment of Achalasia
1 other identifier
observational
200
1 country
1
Brief Summary
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 \& a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021
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 2019
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 6, 2019
CompletedFirst Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 5, 2027
June 10, 2026
June 1, 2026
8 years
November 27, 2019
June 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease or no symptoms of chest pain
To continue and review our treatment outcomes, patient safety in cases with achalasia, we follow up after the procedure up to 180 days. Follow-up period varies from patient to patient.
upto 180 days
Interventions
POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.
Eligibility Criteria
There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019. In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021.
You may qualify if:
- Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
- 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)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prashant Kedia, M.D.
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2019
First Posted
November 23, 2020
Study Start
February 6, 2019
Primary Completion (Estimated)
February 5, 2027
Study Completion (Estimated)
February 5, 2027
Last Updated
June 10, 2026
Record last verified: 2026-06