Pectus Carinatum, ChondromanubrialNCT04171063
Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study
A study testing Thoracic compressor in people with Pectus Carinatum, Chondromanubrial, run by University of Sao Paulo at 4 sites in Brazil.
Trial summary
Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Carinatum, Chondromanubrial
- What is being tested?
- Thoracic compressor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesBrazil
- Study dates
- 1 Nov 2019to 1 Dec 2022
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pectus carinatum condrogladiolar Variant
- No other comorbidities that could interfere with the use of compressor
Who cannot join
- Marfan Syndrome
- Active cardiovascular disease
- Significant scoliosis or thoracic deformity
- Important obesity
- Pectus carinatum chondromanubrial variant
- Poor commitment to protocol by both research participant and parents
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites, 4 recruiting
- Recruiting
Hospital de Clinicas da Faculdade de Botucatu
Botucatu, São Paulo
Daniele Cataneo, +55(14) 3880-1529, dcataneo@fmb.unesp.br
Daniele C Cataneo, MD, PhD
- Recruiting
Hospital das Clinicas da Unicamp
Campinas, São Paulo
Ricardo K Mussi, +55 (19) 3521-9450, rkalaf@fcm.unicamp.br
Ricardo K Mussi, MD, PhD
- Recruiting
Hospital das Clinicas da USP Ribeirao
Ribeirão Preto
Tales R Nadai, +55 (16) 3393-7865, talesusp@yahoo.com.br
Tales R Nadai, MD, PhD
- Recruiting
Instituto do Coracao (InCor) HCFMUSP
São Paulo, São Paulo
Flavio Savazzi, +55(11) 2661-5708, carinatum.incor@gmail.com
Flavio H Savazzi, MD
About this study
Official title: Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.
- Conditions
- Pectus Carinatum, Chondromanubrial
- Being tested
- Thoracic compressor
- Keywords
- Braces, Conservative treatment, Thoracic wall, Pectus carinatum
- Medical subject headings
- Pectus Carinatum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic compressorDevice
The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum
| Study group | Role | What they receive |
|---|---|---|
| Bracing arm | Other | Patients that will be using the thoracic compressor Receives: Device: Thoracic compressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficiency in repairing the pectus carinatum
The anthroprometric measures in centimeters of the thoracic cage will be taken before and after the treatment to evaluate the effectiveness of the chest compressor in repairing the pectus carinatum
Measured: 16 months
Treatment safety
The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair
Measured: 16 months
Secondary outcomes (2)
Treatment adherence
The number of hours of daily use of the chest compressor will be recorded as a measurement of the level of adherence to the chest compressor treatment
Measured: 16 months
Device durability
The mechanic problems presented by the chest compressor as fractures, screw loosening or fastener break will be recorded as a durability and strength measure of the chest compressor and its components.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pectus Carinatum, ChondromanubrialStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will be allocated to use the thoracic compressor for 16 months
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Miguel Tedde, MD, PhD, Principal investigator, Instituto do Coracao (InCor) HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171063
- Sponsor's protocol ID
- USaoPauloGH
- Status last verified
- Oct 2021
- First submitted
- 7 Nov 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly RE Jr, Lawson ML, Paidas CN, Hruban RH. Pectus excavatum in a 112-year autopsy series: anatomic findings and the effect on survival. J Pediatr Surg. 2005 Aug;40(8):1275-8. doi: 10.1016/j.jpedsurg.2005.05.010.
PubMed 16080931Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
PubMed 8641129Kelly RE Jr, Shamberger RC, Mellins RB, Mitchell KK, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley TC, Moskowitz AB. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007 Aug;205(2):205-16. doi: 10.1016/j.jamcollsurg.2007.03.027. Epub 2007 Jun 21.
PubMed 17660066Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.
PubMed 23657247
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
- ClinicalTrials.gov ID
- NCT04171063
- Acronym / sponsor ID
- USaoPauloGH
- Conditions
- Pectus Carinatum, Chondromanubrial
- Keywords
- Braces, Conservative treatment, Thoracic wall, Pectus carinatum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Nov 2019 (actual)
- 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.
Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be allocated to use the thoracic compressor for 16 months
| Arm | Type | Receives |
|---|---|---|
| Bracing arm | Other | Device: Thoracic compressorPatients that will be using the thoracic compressor |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pectus carinatum condrogladiolar Variant
- No other comorbidities that could interfere with the use of compressor
Key exclusion criteria (6 listed)
- Marfan Syndrome
- Active cardiovascular disease
- Significant scoliosis or thoracic deformity
- Important obesity
- Pectus carinatum chondromanubrial variant
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 |
|---|---|---|
| Thoracic compressorThe intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum | Device | Bracing arm |
Primary outcome
Treatment efficiency in repairing the pectus carinatum
Time frame: 16 months
The anthroprometric measures in centimeters of the thoracic cage will be taken before and after the treatment to evaluate the effectiveness of the chest compressor in repairing the pectus carinatum
Treatment safety
Time frame: 16 months
The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair
2 secondary outcomes
Treatment adherence
Time frame: 16 months
Device durability
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 16080931Kelly RE Jr, Lawson ML, Paidas CN, Hruban RH. Pectus excavatum in a 112-year autopsy series: anatomic findings and the effect on survival. J Pediatr Surg. 2005 Aug;40(8):1275-8. doi: 10.1016/j.jpedsurg.2005.05.010.
- Results publication: PubMed 8641129Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
- Results publication: PubMed 17660066Kelly RE Jr, Shamberger RC, Mellins RB, Mitchell KK, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley TC, Moskowitz AB. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007 Aug;205(2):205-16. doi: 10.1016/j.jamcollsurg.2007.03.027. Epub 2007 Jun 21.
- Results publication: PubMed 23657247Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.
- Individual participant dataSharing planned: No
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.
Miguel Tedde, MD, PhD principal investigator
Instituto do Coracao (InCor) HCFMUSP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic compressor in people with Pectus Carinatum, Chondromanubrial, run by University of Sao Paulo at 4 sites in Brazil.
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 2 inclusion and 6 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficiency in repairing the pectus carinatum (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171063, which also lists 4 linked publications.
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 12 Oct 2021.