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

NCT ID: NCT04452721

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Pectus Carinatum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective cohort

340 to 400 patients

dynamic compression system

Intervention Type OTHER

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

Validation cohort

120 patients

dynamic compression system

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aurélien SCALABRE

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Aurélien SCALABRE

Role: CONTACT

04 77 82 94 49

Facility Contacts

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Aurélien SCALABRE

Role: primary

0477829449

Other Identifiers

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20CH030

Identifier Type: -

Identifier Source: org_study_id

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