Assessing the effects of non-surgical treatments for chest wall deformities
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT02528656
This study is testing whether non-surgical treatments for chest wall deformities like pectus excavatum and pectus carinatum can improve breathing, heart function, and overall health in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 10 Years to 30 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-etienne) |
| Trial ID | NCT02528656 on ClinicalTrials.gov |
What this trial studies
This study evaluates the physiological effects of non-operative treatments for chest wall deformities, specifically pectus excavatum and pectus carinatum. It focuses on assessing functional benefits such as ventilation, hemodynamic, and neurologic improvements, which have not been thoroughly evaluated before. The methodology includes non-invasive assessments of respiratory and cardiac function, as well as overall metabolic performance during rest and exercise. Anatomic evaluations will be conducted using MRI and echocardiography to measure changes from initial to final assessments.
Who should consider this trial
Good fit: Ideal candidates include patients with pectus excavatum or pectus carinatum who do not require surgical intervention.
Not a fit: Patients with skeletal diseases, uncontrolled coagulopathies, or specific syndromes like Marfan syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the functional improvements of patients with chest wall deformities, enhancing non-surgical treatment options.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in evaluating non-surgical treatments for chest wall deformities.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with pectus excavatum or pectus carinatum who does not require surgery * Patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :For pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). For pectus excavatum less than 250 mbar depression. * Signed informed consent * Subject (or parents) affiliated to the French National Health Insurance Exclusion Criteria: * Skeletal disease, disturbing bone strength as osteogenesis imperfect and osteoporosis. * Uncontrolled coagulopathies. * Marfan syndrome, with mitral valve prolapse for pectus Excavatum. * Atrial fibrillation * Taking antiarrhythmic drug.
Where this trial is running
Saint-etienne
- CHU de SAINT-ETIENNE — Saint-etienne, France (RECRUITING)
Study contacts
- Principal investigator: Arnaud PATOIR, MD — CHU SAINT-ETIENNE
- Study coordinator: Arnaud PATOIR, MD
- Email: arnaud.patoir@chu-st-etienne.fr
- Phone: (0)477828847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System