Funnel ChestNCT03087734
Evaluation of a New Model of Metallic Bar and Stabilizer for Use in MIRPE
A study testing Implantation of new model of bar with oblique stabilizers and Implantation of regular bar with perpendicular stabilizers in people with Funnel Chest, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Funnel Chest
- What is being tested?
- Implantation of new model of bar with oblique stabilizers and Implantation of regular bar with perpendicular stabilizers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Oct 2017to 1 Mar 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pectus excavatum patients
Who cannot join
- Presence of complex congenital anomalies;
- Retardation neurodevelopment;
- Congenital heart disease;
- Chronic Immunosuppression.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo
About this study
Official title: Evaluation of a New Model of Metallic Bar and Stabilizer for Use in the Minimally Invasive Repair of Pectus Excavatum
Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. In this technique a metal bar is inserted in retrosternal position, pushing the sternum without the necessity of resecting the condral cartilages. Despite the advantages obtained with this technique, it is not without complications and the displacement of the bar is one of the most important. In order to minimize this problem we developed a new model of stabilizers, as well as all necessary instruments for performing minimally invasive surgery. The aim of this study is to compare two surgical groups, one making use of the new oblique stabilizer compared to the conventional perpendicular stabilizer to determine which one has less displacement. Furthermore, this study also aims to assess the full range of instruments developed by a national company, to carry out this type of surgery, which has cost compatible with our economic reality, and that can be accessible to our Public Health patients.
Read the detailed description
Introduction Pectus excavatum (PE) is presented as a sunken sternum in the midline and these chest deformities are not uncommon, occurring in approximately 1/1000.
It is commonly accepted that the abnormal growth of condral cartilage results in displacement of the sternum. Most patients and their parents seek medical advice for psychosocial concerns, particularly related to the cosmetic aspects and the consequent aversion to sports or public exposure. Physiological tests are often normal, but both the cardiac index and pulmonary function may be affected.
Surgical treatment of pectus excavatum Nuss broke the paradigm in PE surgery with the publication of their results using a technique called minimally invasive. This technique involves lateral incisions in the chest and the placement of one or two temporary steel bars, which are shaped during surgery, specifically for each patient. These bars are placed in retrosternal position and the sternum is elevated without the need of cartilage resection.
This surgical technique, in addition to the bars and stabilizers, needs a set of instruments that are used in the customization of the bar for each patient and, after three years, the withdrawal of the bar at the end of the treatment.
Another problem refers to the displacement of the metallic bars that are positioned under the sternum and that are held in position by placing stabilizers, one at each lateral end of the bar. These stabilizers, which are perpendicular to the bar, has the function to expand its area of contact with the chest wall in order to prevent it from moving from its position.
In order to increase the stability of the bar, preventing their movement, various modifications have been proposed. The investigators believe that further modification can be introduced. If the stabilizer metal bar has an oblique position relative to the bar (rather than perpendicular as it is currently) it will be perpendicular to the ribs, thus increasing its area of contact with the chest wall, which might bring more stability.
The investigators are also proposing that the new metal bar that is being developed is completely smooth, not having the usual slots that the current model has at the extremities of the bars. The reason for this is to try to prevent bleeding during bars withdrawal after 3 years of use.
Another proposed amendment is a pressure screw incorporated into the stabilizer itself.
Search object The object of research is the development of a new model of metallic bar and stabilizers, as well as dedicated surgical instruments whose purpose is to perform minimally invasive repairs of PE.
Social relevance One of the reasons why the Public Health in Brazil gives no coverage for this type of surgical treatment for patients with PE is the high cost of surgical equipment that is imported. The development of this material in the country, as is being proposed in this project, has high social relevance that may represent savings by avoiding the purchase of imported material and the possibility of making available this type of surgical treatment for patients served by our public health.
Site of the search The research will be performed in the Department of Thoracic Surgery, Heart Institute (InCor) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo.
- Conditions
- Funnel Chest
- Being tested
- Implantation of new model of bar with oblique stabilizers, Implantation of regular bar with perpendicular stabilizers
- Keywords
- Prostheses and Implants
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of new model of bar with oblique stabilizersDevice
Implantation of new model of bar with oblique stabilizers
Implantation of regular bar with perpendicular stabilizersDevice
Implantation of regular bar with perpendicular stabilizers
| Study group | Role | What they receive |
|---|---|---|
| Perpendicular stabilizer | Active comparator | Implantation of regular bar with perpendicular stabilizers Receives: Device: Implantation of regular bar with perpendicular stabilizers |
| Oblique stabilizer | Experimental | Implantation of new model of bar with oblique stabilizers Receives: Device: Implantation of new model of bar with oblique stabilizers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of metallic bar dislodgment measured through Rx images
The grade of metallic bar dislodgment will be measured through the comparison of the Rx taken in patient follow up in terms of: a) bar flipping; b) lateral sliding and c) hinge-point disruption
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start3 Oct 2017
- Primary completion25 Sep 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Funnel ChestStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Paulo M Pego-Fernandes, Study chair, Heart Institute (InCor), Hospital das Clinicas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087734
- Sponsor's protocol ID
- 2014/15290-7
- Other IDs
- 2014
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2016
- 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
Tedde ML, De Carvalho RLC, De Campos JRM, Da Silva DAG, Okumura EM, Guilherme GF, Marchesi AC, Petrizzo P, Souto Maior BS, Pego-Fernandes PM. Randomized comparison of oblique and perpendicular stabilizers for minimally invasive repair of pectus excavatum. Interdiscip Cardiovasc Thorac Surg. 2024 Mar 5;38(3):ivae040. doi: 10.1093/icvts/ivae040.
PubMed 38492558
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
- Evaluation of a New Model of Metallic Bar and Stabilizer for Use in the Minimally Invasive Repair of Pectus Excavatum
- ClinicalTrials.gov ID
- NCT03087734
- Acronym / sponsor ID
- 2014/15290-7
- Conditions
- Funnel Chest
- Keywords
- Prostheses and Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 22 Mar 2017 (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 excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. In this technique a metal bar is inserted in retrosternal position, pushing the sternum without the necessity of resecting the condral cartilages. Despite the advantages obtained with this technique, it is not without complications and the displacement of the bar is one of the most important. In order to minimize this problem we developed a new model of stabilizers, as well as all necessary instruments for performing minimally invasive surgery. The aim of this study is to compare two surgical groups, one making use of the new oblique stabilizer compared to the conventional perpendicular stabilizer to determine which one has less displacement. Furthermore, this study also aims to assess the full range of instruments developed by a national company, to carry out this type of surgery, which has cost compatible with our economic reality, and that can be accessible to our Public Health patients.
Detailed description
Introduction Pectus excavatum (PE) is presented as a sunken sternum in the midline and these chest deformities are not uncommon, occurring in approximately 1/1000.
It is commonly accepted that the abnormal growth of condral cartilage results in displacement of the sternum. Most patients and their parents seek medical advice for psychosocial concerns, particularly related to the cosmetic aspects and the consequent aversion to sports or public exposure. Physiological tests are often normal, but both the cardiac index and pulmonary function may be affected.
Surgical treatment of pectus excavatum Nuss broke the paradigm in PE surgery with the publication of their results using a technique called minimally invasive. This technique involves lateral incisions in the chest and the placement of one or two temporary steel bars, which are shaped during surgery, specifically for each patient. These bars are placed in retrosternal position and the sternum is elevated without the need of cartilage resection.
This surgical technique, in addition to the bars and stabilizers, needs a set of instruments that are used in the customization of the bar for each patient and, after three years, the withdrawal of the bar at the end of the treatment.
Another problem refers to the displacement of the metallic bars that are positioned under the sternum and that are held in position by placing stabilizers, one at each lateral end of the bar. These stabilizers, which are perpendicular to the bar, has the function to expand its area of contact with the chest wall in order to prevent it from moving from its position.
In order to increase the stability of the bar, preventing their movement, various modifications have been proposed. The investigators believe that further modification can be introduced. If the stabilizer metal bar has an oblique position relative to the bar (rather than perpendicular as it is currently) it will be perpendicular to the ribs, thus increasing its area of contact with the chest wall, which might bring more stability.
The investigators are also proposing that the new metal bar that is being developed is completely smooth, not having the usual slots that the current model has at the extremities of the bars. The reason for this is to try to prevent bleeding during bars withdrawal after 3 years of use.
Another proposed amendment is a pressure screw incorporated into the stabilizer itself.
Search object The object of research is the development of a new model of metallic bar and stabilizers, as well as dedicated surgical instruments whose purpose is to perform minimally invasive repairs of PE.
Social relevance One of the reasons why the Public Health in Brazil gives no coverage for this type of surgical treatment for patients with PE is the high cost of surgical equipment that is imported. The development of this material in the country, as is being proposed in this project, has high social relevance that may represent savings by avoiding the purchase of imported material and the possibility of making available this type of surgical treatment for patients served by our public health.
Site of the search The research will be performed in the Department of Thoracic Surgery, Heart Institute (InCor) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perpendicular stabilizer | Active comparator | Device: Implantation of regular bar with perpendicular stabilizersImplantation of regular bar with perpendicular stabilizers |
| Oblique stabilizer | Experimental | Device: Implantation of new model of bar with oblique stabilizersImplantation of new model of bar with oblique stabilizers |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pectus excavatum patients
Key exclusion criteria (4 listed)
- Presence of complex congenital anomalies;
- Retardation neurodevelopment;
- Congenital heart disease;
- Chronic Immunosuppression.
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 |
|---|---|---|
| Implantation of new model of bar with oblique stabilizersImplantation of new model of bar with oblique stabilizers | Device | Oblique stabilizer |
| Implantation of regular bar with perpendicular stabilizersImplantation of regular bar with perpendicular stabilizers | Device | Perpendicular stabilizer |
Primary outcome
Grade of metallic bar dislodgment measured through Rx images
Time frame: One year
The grade of metallic bar dislodgment will be measured through the comparison of the Rx taken in patient follow up in terms of: a) bar flipping; b) lateral sliding and c) hinge-point disruption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 38492558Tedde ML, De Carvalho RLC, De Campos JRM, Da Silva DAG, Okumura EM, Guilherme GF, Marchesi AC, Petrizzo P, Souto Maior BS, Pego-Fernandes PM. Randomized comparison of oblique and perpendicular stabilizers for minimally invasive repair of pectus excavatum. Interdiscip Cardiovasc Thorac Surg. 2024 Mar 5;38(3):ivae040. doi: 10.1093/icvts/ivae040.
- 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.
Paulo M Pego-Fernandes study chair
Heart Institute (InCor), Hospital das Clinicas, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of new model of bar with oblique stabilizers and Implantation of regular bar with perpendicular stabilizers in people with Funnel Chest, run by University of Sao Paulo at 1 site 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 1 inclusion and 4 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of metallic bar dislodgment measured through Rx images (time frame: One year). 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 NCT03087734, which also lists 1 linked publication.
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.