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

October 25, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Étienne, France, 42055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Refusal to participate to this treatment

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort
340 to 400 patients
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
Validation cohort
120 patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Dynamic compression system
After the end of treatment (6 months to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Aurélien SCALABRE, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20CH030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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