An interventional study of Three-dimensional imaging in Pectus Excavatum and Funnel Chest, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Basic science
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.
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 40 across 46 interventional 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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Exclusion Criteria:
Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.
Diagnostic Test: Three-dimensional imaging
Three-dimensional surface images, acquired by the Artec Leo
Mean change in chest wall dimensions
difference between baseline (first image) and image after application of the Crane technique
Time frame: 1 hour
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2020 (actual). Primary completion is estimated for Mar 2021, 10 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 10 months is below that.
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This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum