- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498699
Quantifying Changes in the Thoracic Wall After Nuss Bar Removal in Pectus Excavatum Patients Using 3D Imaging (CHEST)
Quantification of Thoracic Wall Changes Using Three-dimensional Optical Imaging After Nuss Bar Removal
Pectus excavatum (funnel chest) is the most common congenital anterior thoracic wall deformity. It can be associated not only with cosmetic concerns but also with psychosocial and limiting somatic complaints. Patients with this condition are often treated surgically using the Nuss bar procedure, in which a metal bar is placed behind the sternum to effectively "pop out" the funnel chest. This bar typically remains in place for 2-3 years.
To analyze how the thoracic wall changes after removal of the Nuss bar, we aim to capture three-dimensional (3D) images at four different time points: just before removal, immediately after, and at 6 and 12 months post-removal. When significant changes over time are detected, we aim to identify factors that may predict retraction or recurrence. Based on these predictive factors, individualized decision-making regarding the timing of Nuss bar removal can be optimized to minimize the risk of retraction or recurrence.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Heerlen, Netherlands
- Zuyderland Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients of all ages and genders with a Nuss bar eligible for removal.
Exclusion Criteria:
- Patients in whom the bar or stabilizing components were dislocated
- Patients who underwent a second surgery for their pectus excavatum following the initial placement of the Nuss bar
- Patients in whom retrosternal metal bars have been placed for any indication other than the treatment of pectus excavatum
- Patients with connective tissue disorders such as Marfan syndrome
- Patients diagnosed with epilepsy
- Patients who are unable to maintain a stationary standing position for approximately 60 seconds
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Postoperative 3D scans
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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External Haller index
Time Frame: just before removal, immediately after, and at 6 and 12 months post-removal.
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just before removal, immediately after, and at 6 and 12 months post-removal.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z2019101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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