redoPOEM : Failure of a First POEM
redoPOEM
Efficacy and Safety After Failure of a First POEM
1 other identifier
observational
111
1 country
14
Brief Summary
observational study, measurement of efficacy in the cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedJuly 10, 2024
July 1, 2024
5 months
August 10, 2023
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy : score of Eckardt
Evaluation of Eckardt score at 3 months after redoPOEM strictly less than 4. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.
3 months after redoPOEM
Secondary Outcomes (3)
Safety : Number of adverse events of grade II
Through study completion, an average of 1 year
Efficacy : Number of Eckart score strictly below 4
Through study completion, an average of 1 year
Efficacy : Number of new additional procedure
Through study completion, an average of 1 year
Eligibility Criteria
patient with achalasia and failure after POEM treated with a new POEM
You may qualify if:
- adult patient
- diagnosis of achalasia based on clinical criteria according to Eckardt score, manometry, and radiology when available.
- failure after POEM (Eckardt score \> or equal to 4 in consultation) treated with a new POEM.
- no active digestive neoplasia.
You may not qualify if:
- Technical failure of redoPOEM
- Person not affiliated to a Social Security scheme
- Language barrier preventing fair collection of non-opposition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Chu de Bordeaux
Bordeaux, France
Clinique des Cèdres
Cornebarrieu, 31700, France
CHU Dijon Bourgogne
Dijon, 21079, France
Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
La Seyne-sur-Mer, 83500, France
CHU Lille
Lille, 59037, France
CHU de Limoges
Limoges, 81042, France
Hospices civils de Lyon
Lyon, 69003, France
Hôpitaux Universitaires de Marseille Nord
Marseille, 13915, France
CHU de Nantes
Nantes, 44093, France
CHU de Nice - Hôpital Archet
Nice, 06200, France
CHU de Nîmes
Nîmes, 30029, France
AP-HP Hôpital Cochin
Paris, 75014, France
CHU de Rennes
Rennes, 35033, France
CHRU de Nancy
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
D'Angelo A, Pioche M, Barret M, Gonzalez JM, Wallenhorst T, Coron E, Velut G, Vanbiervliet G, Onana Ndong P, Jacques J, Schaefer M, Levy J, Caillo L, Rahmi G, Aidibi A, Ah-Soune P, Degand T, Saunier M, Zerbib F, Berger A. RedoPOEM: efficacy and safety after failure of a first POEM for esophageal motility disorders. Surg Endosc. 2026 Jan 23. doi: 10.1007/s00464-026-12564-4. Online ahead of print.
PMID: 41575544DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arthur BERGER, MD
University Hospital, Bordeaux
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2023
First Posted
September 21, 2023
Study Start
October 3, 2023
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share