Pectus ExcavatumNCT01816373
Non-invasive Negative Pressure Treatment for Pectus Excavatum
A study testing Vacuum Bell in people with Pectus Excavatum, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment Read more about this study
- Who is it for?
- Ages 8 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Vacuum Bell
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBrazil
- Study dates
- Mar 2013to Oct 2016
- 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 8 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- absence of co-morbidities that may interfere with proper placement or function of the apparatus
- test negative for pregnancy in women of childbearing age
Who cannot join
- skeletal diseases like osteogenesis imperfecta or osteoporosis
- clotting disorders such as hemophilia or thrombopathia
- skin diseases or infections of the anterior chest wall
- angiopathies or vascular fragility
- obesity important with BMI greater than 30
- precarious commitment to the prolonged use of the device protocol
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 05403-000
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
São Paulo, 05403900
About this study
Official title: Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment
- Conditions
- Pectus Excavatum
- Being tested
- Vacuum Bell
- Keywords
- Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
- Medical subject headings
- Funnel Chest, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum BellDevice
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Bell | Other | Patients with pectus excavatum will be treated with the Vacuum Bell device Receives: Device: Vacuum Bell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the reduction in the deepness of the pectus excavatum
The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study
Measured: 3 months
Secondary outcomes (1)
Evaluation of quality of life related to self-esteem
The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device
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 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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 L. Tedde, MD, PhD, Principal investigator, Instituto do Coracao (InCor), Hospital das Clinicas, FMUSPJose Ribas M de Campos, MD, PhD, Study chair, Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816373
- Sponsor's protocol ID
- SDC 3591/11/009
- Other IDs
- 2011/51156-5
- Status last verified
- May 2017
- First submitted
- 18 Mar 2013
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haecker FM, Sesia SB. Intraoperative use of the vacuum bell for elevating the sternum during the Nuss procedure. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):934-6. doi: 10.1089/lap.2012.0030.
PubMed 23137116Schier F, Bahr M, Klobe E. The vacuum chest wall lifter: an innovative, nonsurgical addition to the management of pectus excavatum. J Pediatr Surg. 2005 Mar;40(3):496-500. doi: 10.1016/j.jpedsurg.2004.11.033.
PubMed 15793724Togoro SY, Tedde ML, Eisinger RS, Okumura EM, de Campos JRM, Pego-Fernandes PM. The Vacuum Bell device as a sternal lifter: An immediate effect even with a short time use. J Pediatr Surg. 2018 Mar;53(3):406-410. doi: 10.1016/j.jpedsurg.2017.04.016. Epub 2017 May 1.
PubMed 28495420
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
- ClinicalTrials.gov ID
- NCT01816373
- Acronym / sponsor ID
- SDC 3591/11/009
- Conditions
- Pectus Excavatum
- Keywords
- Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Mar 2013 (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 purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vacuum Bell | Other | Device: Vacuum BellPatients with pectus excavatum will be treated with the Vacuum Bell device |
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- absence of co-morbidities that may interfere with proper placement or function of the apparatus
- test negative for pregnancy in women of childbearing age
Key exclusion criteria (6 listed)
- skeletal diseases like osteogenesis imperfecta or osteoporosis
- clotting disorders such as hemophilia or thrombopathia
- skin diseases or infections of the anterior chest wall
- angiopathies or vascular fragility
- obesity important with BMI greater than 30
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 with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device | Device | Vacuum Bell |
Primary outcome
Measurement of the reduction in the deepness of the pectus excavatum
Time frame: 3 months
The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study
1 secondary outcome
Evaluation of quality of life related to self-esteem
Time frame: One year
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 25 May 2017.
- Background: PubMed 23137116Haecker FM, Sesia SB. Intraoperative use of the vacuum bell for elevating the sternum during the Nuss procedure. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):934-6. doi: 10.1089/lap.2012.0030.
- Background: PubMed 15793724Schier F, Bahr M, Klobe E. The vacuum chest wall lifter: an innovative, nonsurgical addition to the management of pectus excavatum. J Pediatr Surg. 2005 Mar;40(3):496-500. doi: 10.1016/j.jpedsurg.2004.11.033.
- Results publication: PubMed 28495420Togoro SY, Tedde ML, Eisinger RS, Okumura EM, de Campos JRM, Pego-Fernandes PM. The Vacuum Bell device as a sternal lifter: An immediate effect even with a short time use. J Pediatr Surg. 2018 Mar;53(3):406-410. doi: 10.1016/j.jpedsurg.2017.04.016. Epub 2017 May 1.
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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.
Miguel L. Tedde, MD, PhD principal investigator
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
Jose Ribas M de Campos, MD, PhD study chair
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Bell in people with Pectus Excavatum, run by University of Sao Paulo at 2 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: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Measurement of the reduction in the deepness of the pectus excavatum (time frame: 3 months). 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 NCT01816373, which also lists 3 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 25 May 2017.