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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/51156-5 | Other Identifier | FAPESP |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum Bell | Other | Patients with pectus excavatum will be treated with the Vacuum Bell device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum Bell | Device | Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and adherence to the treatment | The patients will be followed to assure adherence and safety of the treatment | three months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel L. Tedde, MD, PhD | Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP | Principal Investigator |
| Jose Ribas M de Campos, MD, PhD | Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 05403-000 | Brazil | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23137116 | Background | 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. | |
| 15793724 | Background | Schier 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. |
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| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
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| Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP |
| São Paulo |
| 05403900 |
| Brazil |
| 28495420 | Result | Togoro 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |