An interventional study of Vacuum Bell and Dynamic Compression System in Pectus Excavatum and Pectus Carinatum, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 10 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Treatment
The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated.
Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods.
Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography.
Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 52 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.
Device: Vacuum Bell
Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.
Device: Dynamic Compression System
Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
Patients will be submitted to a dynamic compression system.
High frequency normalized index (HFnu)
It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor
Time frame: One month after the end of treatment
Low frequency (LF and LFnu)
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Time frame: One month after the end of treatment
LF/HF ratio
It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor.
Time frame: One month after the end of treatment
Blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Time frame: One month after the end of treatment
Lung residual volume
It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing.
Time frame: One month after the end of treatment
Maximum flow
It is expressed in litres per minute and is measured during a pulmonary function testing. The patient is seated and his/her nose is blocked with a clamp. He/She must blow as fast and as hard as possible.
Time frame: One month after the end of treatment
Aerobic maximum power
It is measured by a stress test (incremental exercise)
Time frame: One month after the end of treatment
Maximum heart rate
It is measured by a stress test (incremental exercise)
Time frame: One month after the end of treatment
Left ventricular ejection fraction
It is measured by an echocardiography
Time frame: One month after the end of treatment
Severity index of the anatomical damage
It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine.
Time frame: One month after the end of treatment
Nuss Questionnaire
It is a depression scale
Time frame: One month after the end of treatment
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2015 (actual). Primary completion is estimated for Jun 2024, 113 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 113 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire de Saint Etienne →