Right Aortic ArchNCT06402682
Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?
An observational study of Right Aortic Arch, run by Fondation Lenval at 1 site in France.
Trial summary
Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Right Aortic Arch
- What is being tested?
- Right approach and Left approach
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2024to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients born with esophageal atresia and right aortic arch between 1990 et 2022
Who may be able to join
- Having been operated on for esophageal atresia and right aortic arch
Who cannot join
- NO
Trial locations and contacts
1 site in 1 country.
Jean-François Lecompte, MD contact
France1 site, 1 recruiting
- Recruiting
Fondation Lenval
Nice, 06200
Jourisse Meye, MD, +33767332556, meye.j@chu-nice.fr
Jean-François Lecompte, MD, jean-francois.lecompte@hpu.lenval.com
About this study
Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective surgical strategy and identify associated complications.
- Conditions
- Right Aortic Arch
- Being tested
- Right approach, Left approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right approachProcedure or surgery
Right approach of the management of esophageal atresia with a right aortic arch
Left approachProcedure or surgery
Left approach of the management of esophageal atresia with a right aortic arch
| Study group | Role | What they receive |
|---|---|---|
| Right approach | Not described Receives: Procedure: Right approach | |
| Left approach | Not described Receives: Procedure: Left approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Post-operative complications after Esophageal atresia repair
Measured: During the first 40 post-operative days
Secondary outcomes (1)
specific complications
Specific complications related to esophageal atresia and right aortic arch repair. The secondary outcome assessment was based on the declaration of clinical post-operative complications on patients medical file"
Measured: During the first 40 post-operative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start15 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Aortic ArchStudies of the same condition, open and under way.
- 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402682
- Sponsor's protocol ID
- 24-HPNCL-02
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Esophageal Atresia With Right Aortic Arch: Is the Side of Approach Important?
- ClinicalTrials.gov ID
- NCT06402682
- Acronym / sponsor ID
- 24-HPNCL-02
- Conditions
- Right Aortic Arch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 May 2024 (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.
Esophageal atresia is associated with a right aortic arch in 2 to 13% of cases. Despite previous studies, consensus on the optimal surgical approach remains lacking. This study aims to analyze the management of esophageal atresia with a right aortic arch in France over three decades, to define the most effective surgical strategy and identify associated complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right approach | – | Procedure: Right approach |
| Left approach | – | Procedure: Left approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients born with esophageal atresia and right aortic arch between 1990 et 2022
Key inclusion criteria (1 listed)
- Having been operated on for esophageal atresia and right aortic arch
Key exclusion criteria (1 listed)
- NO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right approachRight approach of the management of esophageal atresia with a right aortic arch | Procedure or surgery | Right approach |
| Left approachLeft approach of the management of esophageal atresia with a right aortic arch | Procedure or surgery | Left approach |
Primary outcome
Post-operative complications
Time frame: During the first 40 post-operative days
Post-operative complications after Esophageal atresia repair
1 secondary outcome
specific complications
Time frame: During the first 40 post-operative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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.
Jean-François Lecompte, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Aortic Arch, run by Fondation Lenval at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jourisse Meye, MD (+33767332556, meye.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications (time frame: During the first 40 post-operative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2024.