Non-invasive Negative Pressure Treatment for Pectus Excavatum

NCT01816373 | Completed DMC

• 2 other identifiers: SDC 3591/11/0092011/51156-5
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Pectus Excavatum

Keywords

Chest wall; Chest, funnel; pectus excavatum; congenital abnormality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of quality of life related to self-esteem

  One year

Other Outcomes (1)

• Evaluate the safety and adherence to the treatment

  three months

Study Arms (1)

Vacuum Bell

OTHER

Patients with pectus excavatum will be treated with the Vacuum Bell device

Device: Vacuum Bell

Interventions

Vacuum Bell DEVICE

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

Vacuum Bell

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• absence of co-morbidities that may interfere with proper placement or function of the apparatus
• test negative for pregnancy in women of childbearing age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-000, Brazil

Location

Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP

São Paulo, 05403900, Brazil

Location

Related 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.

  PMID: 23137116 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.

  PMID: 15793724 BACKGROUND

• 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.

  PMID: 28495420 RESULT

MeSH Terms

Conditions

Funnel Chest; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 22, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

BR (2)