AchalasiaredoPOEMNCT06044155
redoPOEM : Failure of a First POEM
An observational study of Achalasia, run by University Hospital, Bordeaux at 14 sites in France.
Trial summary
observational study, measurement of efficacy in the cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- How many people
- 111 participants
- Where
- 14 sitesFrance
- Study dates
- 3 Oct 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with achalasia and failure after POEM treated with a new POEM
Who may be able to join
- 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.
Who cannot join
- Technical failure of redoPOEM
- Person not affiliated to a Social Security scheme
- Language barrier preventing fair collection of non-opposition.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Chu de Bordeaux
Bordeaux
Clinique des Cèdres
Cornebarrieu, 31700
CHU Dijon Bourgogne
Dijon, 21079
Centre Hospitalier Intercommunal de Toulon - La Seyne-sur-Mer
La Seyne-sur-Mer, 83500
CHU Lille
Lille, 59037
CHU de Limoges
Limoges, 81042
Hospices civils de Lyon
Lyon, 69003
Hôpitaux Universitaires de Marseille Nord
Marseille, 13915
CHU de Nantes
Nantes, 44093
CHU de Nice - Hôpital Archet
Nice, 06200
CHU de Nîmes
Nîmes, 30029
AP-HP Hôpital Cochin
Paris, 75014
CHU de Rennes
Rennes, 35033
CHRU de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Efficacy and Safety After Failure of a First POEM
observational study, measurement of efficacy in the cohort.
Read the detailed description
Achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. Multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the Heller myotomy technique. These techniques are moderately effective and/or carry the risk of per- and post-procedural complications. POEM has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. In the event of failure of a first POEM, a second POEM, known as "redoPOEM", can be proposed. Several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. However, the studies carried out involved small numbers of patients, generally around 50, the vast majority in Asian countries. The aim of this study was therefore to evaluate the efficacy and safety of redoPOEM reported in patients from several expert centers in Europe.
- Conditions
- Achalasia
- Keywords
- achalasia, redoPOEM, POEM, per-oral endoscopic myotomy, retrospective, multicenter, efficacy
- Medical subject headings
- Esophageal Achalasia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after redoPOEM
Secondary outcomes (3)
Safety : Number of adverse events of grade II
Evaluation of absence of adverse events of grade II or higher according to AGREE classification.
Measured: Through study completion, an average of 1 year
Efficacy : Number of Eckart score strictly below 4
Evaluation of Eckardt score strictly below 4 at last known follow-up after redoPOEM. Each question is rated from 0 to 3. It consists of 4 items with a total score varies from 0 to 12.
Measured: Through study completion, an average of 1 year
Efficacy : Number of new additional procedure
Evaluation of number of an additional procedure because of failure of redoPOEM.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start3 Oct 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur BERGER, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044155
- Sponsor's protocol ID
- CHUBX 2023/17
- Acronym
- redoPOEM
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Apr;40(4):3090-3098. doi: 10.1007/s00464-026-12564-4. Epub 2026 Jan 23.
PubMed 41575544
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety After Failure of a First POEM
- ClinicalTrials.gov ID
- NCT06044155
- Acronym / sponsor ID
- redoPOEM / CHUBX 2023/17
- Conditions
- Achalasia
- Keywords
- achalasia, redoPOEM, POEM, per-oral endoscopic myotomy, retrospective, multicenter, efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
observational study, measurement of efficacy in the cohort.
Detailed description
Achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. Multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the Heller myotomy technique. These techniques are moderately effective and/or carry the risk of per- and post-procedural complications. POEM has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. In the event of failure of a first POEM, a second POEM, known as "redoPOEM", can be proposed. Several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. However, the studies carried out involved small numbers of patients, generally around 50, the vast majority in Asian countries. The aim of this study was therefore to evaluate the efficacy and safety of redoPOEM reported in patients from several expert centers in Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with achalasia and failure after POEM treated with a new POEM
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Technical failure of redoPOEM
- Person not affiliated to a Social Security scheme
- Language barrier preventing fair collection of non-opposition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy : score of Eckardt
Time frame: 3 months after redoPOEM
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 secondary outcomes
Safety : Number of adverse events of grade II
Time frame: Through study completion, an average of 1 year
Efficacy : Number of Eckart score strictly below 4
Time frame: Through study completion, an average of 1 year
Efficacy : Number of new additional procedure
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 41575544D'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 Apr;40(4):3090-3098. doi: 10.1007/s00464-026-12564-4. Epub 2026 Jan 23.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur BERGER, MD principal investigator
University Hospital, Bordeaux
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia, run by University Hospital, Bordeaux at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : score of Eckardt (time frame: 3 months after redoPOEM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06044155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.