Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System

Pectus Carinatum Clinical Trial

— Pectusdyn  

Official title:

Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452721
• Other study ID #: 20CH030
• Status: Recruiting
• Start date: July 7, 2020
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Aurélien SCALABRE
• Phone: 04 77 82 94 49
• Email: aurelien.scalabre[@]chu-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Pectus Carinatum

Intervention

Other:
• dynamic compression system
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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment	Dynamic compression system	After 6 months of treatment
Secondary	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	After the end of treatment (6 months to 2 years)