Back to resultsNon-invasive Negative Pressure Treatment for Pectus Excavatum
Primary Purpose
Pectus Excavatum
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Vacuum Bell
Sponsored by
About this trial
This is an interventional treatment trial for Pectus Excavatum focused on measuring Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
Eligibility Criteria
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
Sites / Locations
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
- Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vacuum Bell
Arm Description
Patients with pectus excavatum will be treated with the Vacuum Bell device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01816373
Brief Title
Non-invasive Negative Pressure Treatment for Pectus Excavatum
Official Title
Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vacuum Bell
Arm Type
Other
Arm Description
Patients with pectus excavatum will be treated with the Vacuum Bell device
Intervention Type
Device
Intervention Name(s)
Vacuum Bell
Intervention Description
Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device
Primary Outcome Measure Information:
Title
Measurement of the reduction in the deepness of the pectus excavatum
Description
The patients will be submitted to clinical measurement of their anterior chest wall at three months interval until the closing of the study
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluation of quality of life related to self-esteem
Description
The patients and their parents will be submitted to a quality of life questionnaire in the beginning and after one year using the device
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Evaluate the safety and adherence to the treatment
Description
The patients will be followed to assure adherence and safety of the treatment
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel L. Tedde, MD, PhD
Organizational Affiliation
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Ribas M de Campos, MD, PhD
Organizational Affiliation
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
City
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23137116
Citation
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.
Results Reference
background
PubMed Identifier
15793724
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. doi: 10.1016/j.jpedsurg.2004.11.033.
Results Reference
background
PubMed Identifier
28495420
Citation
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.
Results Reference
result
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Non-invasive Negative Pressure Treatment for Pectus Excavatum
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