Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging (CRANE)
Primary Purpose
Pectus Excavatum, Funnel Chest
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Three-dimensional imaging
Sponsored by
About this trial
This is an interventional basic science trial for Pectus Excavatum
Eligibility Criteria
Inclusion Criteria:
- Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.
Exclusion Criteria:
- None
Sites / Locations
- Zuyderland Medical CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Three-dimensional imaging
Arm Description
Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.
Outcomes
Primary Outcome Measures
Mean change in chest wall dimensions
difference between baseline (first image) and image after application of the Crane technique
Secondary Outcome Measures
Full Information
NCT ID
NCT04418583
First Posted
May 20, 2020
Last Updated
November 2, 2020
Sponsor
Zuyderland Medisch Centrum
1. Study Identification
Unique Protocol Identification Number
NCT04418583
Brief Title
Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
Acronym
CRANE
Official Title
Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zuyderland Medisch Centrum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Funnel Chest
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective case-control study wherein participants are their own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Three-dimensional imaging
Arm Type
Experimental
Arm Description
Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.
Intervention Type
Diagnostic Test
Intervention Name(s)
Three-dimensional imaging
Intervention Description
Three-dimensional surface images, acquired by the Artec Leo
Primary Outcome Measure Information:
Title
Mean change in chest wall dimensions
Description
difference between baseline (first image) and image after application of the Crane technique
Time Frame
1 hour
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.
Exclusion Criteria:
None
Facility Information:
Facility Name
Zuyderland Medical Centre
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Daemen
Phone
+314597777
Email
j.daemen@zuyderland.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
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