Pectus CarinatumPectusdynNCT04452721
Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
An observational study of Pectus Carinatum, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on… Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Pectus Carinatum
- What is being tested?
- dynamic compression system
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Refusal to participate to this treatment
Who may be able to join
- Patient who received proper information about the study.
- Patient with clinically diagnosed pectus carinatum.
- Treated at Saint-Etienne University Hospital using a dynamic compression system.
- Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
- With more than 6 months of follow-up since the beginning of the treatment.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Aurélien SCALABRE, 0477829449, aurelien.scalabre@chu-st-etienne.fr
Aurélien SCALABRE
About this study
Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.
Read the detailed description
The principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.
- Conditions
- Pectus Carinatum
- Being tested
- dynamic compression system
- Keywords
- Pectus Carinatum, Dynamic compression system
- Medical subject headings
- Pectus Carinatum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic compression systemOther
It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | 340 to 400 patients Receives: Other: dynamic compression system | |
| Validation cohort | 120 patients Receives: Other: dynamic compression system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
Dynamic compression system
Measured: After 6 months of treatment
Secondary outcomes (1)
Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed
Dynamic compression system
Measured: After the end of treatment (6 months to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start7 Jul 2020
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
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 Pectus CarinatumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien SCALABRE, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452721
- Sponsor's protocol ID
- 20CH030
- Acronym
- Pectusdyn
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2020
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kieffer De Marco L, Filaire L, Vermersch S, Chapelle C, Garcin A, Tiffet O, Scalabre A. Prognostic Factors for Pectus Carinatum Treated by Dynamic Compression System: PECTUSDYN Trial. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf444. doi: 10.1093/ejcts/ezaf444.
PubMed 41390917
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
- ClinicalTrials.gov ID
- NCT04452721
- Acronym / sponsor ID
- Pectusdyn / 20CH030
- Conditions
- Pectus Carinatum
- Keywords
- Pectus Carinatum, Dynamic compression system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 30 Jun 2020 (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.
Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.
Detailed description
The principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Other: dynamic compression system340 to 400 patients |
| Validation cohort | – | Other: dynamic compression system120 patients |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Refusal to participate to this treatment
Key inclusion criteria (5 listed)
- Patient who received proper information about the study.
- Patient with clinically diagnosed pectus carinatum.
- Treated at Saint-Etienne University Hospital using a dynamic compression system.
- Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
- With more than 6 months of follow-up since the beginning of the treatment.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| dynamic compression systemIt is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it | Other | Retrospective cohort, Validation cohort |
Primary outcome
Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
Time frame: After 6 months of treatment
Dynamic compression system
1 secondary outcome
Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed
Time frame: After the end of treatment (6 months to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 41390917Kieffer De Marco L, Filaire L, Vermersch S, Chapelle C, Garcin A, Tiffet O, Scalabre A. Prognostic Factors for Pectus Carinatum Treated by Dynamic Compression System: PECTUSDYN Trial. Eur J Cardiothorac Surg. 2026 Jan 6;68(1):ezaf444. doi: 10.1093/ejcts/ezaf444.
- Individual participant dataSharing planned: No
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.
Aurélien SCALABRE principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Pectus Carinatum, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélien SCALABRE (04 77 82 94 49, aurelien.scalabre@chu-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment (time frame: After 6 months of treatment). 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 NCT04452721, 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 29 Jan 2025.