Pectus ExcavatumPECTUSNCT02528656
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities
A study testing Vacuum Bell and Dynamic Compression System in people with Pectus Excavatum and Pectus Carinatum, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Pectus Excavatum, Pectus Carinatum
- What is being tested?
- Vacuum Bell and Dynamic Compression System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2015to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
Francois VARLET, MD PhD
Olivier TIFFET, MD PhD
About this study
Official title: Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
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.
Read more
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.
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Being tested
- Vacuum Bell, Dynamic Compression System
- Keywords
- Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System
- Medical subject headings
- Funnel Chest, Pectus Carinatum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum BellDevice
Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
Dynamic Compression SystemDevice
Patients will be submitted to a dynamic compression system.
| Study group | Role | What they receive |
|---|---|---|
| Pectus Excavatum | Experimental | Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device. Receives: Device: Vacuum Bell |
| Pectus Carinatum | Experimental | Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System. Receives: Device: Dynamic Compression System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month after the end of treatment
Secondary outcomes (10)
Low frequency (LF and LFnu)
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Measured: 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.
Measured: One month after the end of treatment
Blood pressure - Baroreflex
Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure
Measured: 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.
Measured: 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.
Measured: One month after the end of treatment
Aerobic maximum power
It is measured by a stress test (incremental exercise)
Measured: One month after the end of treatment
Maximum heart rate
It is measured by a stress test (incremental exercise)
Measured: One month after the end of treatment
Left ventricular ejection fraction
It is measured by an echocardiography
Measured: 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.
Measured: One month after the end of treatment
Nuss Questionnaire
It is a depression scale
Measured: One month after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start12 Jan 2015
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- MEDICALEX
- Responsible party
- Sponsor
- Investigators
- Manuel LOPEZ, MD, Study chair, CHU de SAINT-ETIENNEArnaud PATOIR, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528656
- Sponsor's protocol ID
- 1408081
- Other IDs
- 2014-A00841-46
- Acronym
- PECTUS
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2015
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study
- ClinicalTrials.gov ID
- NCT02528656
- Acronym / sponsor ID
- PECTUS / 1408081
- Conditions
- Pectus Excavatum, Pectus Carinatum
- Keywords
- Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- MEDICALEX
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectus Excavatum | Experimental | Device: Vacuum BellPatients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device. |
| Pectus Carinatum | Experimental | Device: Dynamic Compression SystemPatients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum BellPatients will be submitted to a negative pressure treatment with the Vacuum Bell device. | Device | Pectus Excavatum |
| Dynamic Compression SystemPatients will be submitted to a dynamic compression system. | Device | Pectus Carinatum |
Primary outcome
High frequency normalized index (HFnu)
Time frame: One month after the end of treatment
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
10 secondary outcomes
Low frequency (LF and LFnu)
Time frame: One month after the end of treatment
LF/HF ratio
Time frame: One month after the end of treatment
Blood pressure - Baroreflex
Time frame: One month after the end of treatment
Lung residual volume
Time frame: One month after the end of treatment
Maximum flow
Time frame: One month after the end of treatment
Aerobic maximum power
Time frame: One month after the end of treatment
Maximum heart rate
Time frame: One month after the end of treatment
Left ventricular ejection fraction
Time frame: One month after the end of treatment
Severity index of the anatomical damage
Time frame: One month after the end of treatment
Nuss Questionnaire
Time frame: One month after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel LOPEZ, MD study chair
CHU de SAINT-ETIENNE
Arnaud PATOIR, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Bell and Dynamic Compression System in people with Pectus Excavatum and Pectus Carinatum, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud PATOIR, MD ((0)477828847 ext. +33, arnaud.patoir@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High frequency normalized index (HFnu) (time frame: One month after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.