An observational study in Pectus Excavatum, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by Zuyderland Medisch Centrum · Observational
Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 12 is below the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Patients that received a three-dimensional optical surface scan to quatify their pectus deformity utilizing the external Haller Index. Patients were retrospectively recruited from the 3DPECTUS study (METCZ20190048; NCT03926078).
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Exclusion Criteria:
Patient position
The effect of patient position on the value of the external Haller Index, based on 3D scans.
Time frame: 5 months
Manual versus automatic alignment of patient position
If there is a significant effect of patient position on the external Haller Index, the ideal correction method is investigated (manual alignment versus automatic, computer-based alignment)
Time frame: 5 months
Start is estimated for Jan 2021; primary completion for Mar 2021, 2 months later.
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum