Non-invasive Negative Pressure Treatment for Pectus Excavatum

Pectus Excavatum Clinical Trial

Official title:

Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816373
• Other study ID #: SDC 3591/11/009
• Secondary ID: 2011/51156-5
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: May 23, 2017
• Start date: March 2013
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 35 Years

Eligibility

Inclusion Criteria:

• absence of co-morbidities that may interfere with proper placement or function of the apparatus

• test negative for pregnancy in women of childbearing age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Device:
• Vacuum Bell
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo
Brazil	Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

Togoro SY, Tedde ML, Eisinger RS, Okumura EM, de Campos JRM, Pêgo-Fernandes PM. The Vacuum Bell device as a sternal lifter: An immediate effect even with a short time use. J Pediatr Surg. 2017 May 1. pii: S0022-3468(17)30257-9. doi: 10.1016/j.jpedsurg.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the safety and adherence to the treatment	The patients will be followed to assure adherence and safety of the treatment	three months
Primary	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
Secondary	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