Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans (CHEST)
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|ClinicalTrials.gov Identifier: NCT04052321|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pectus Excavatum||Other: 3D optical surface scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: 3D scan arm
This is a single arm study. Patients in this arm will receive a 3D scan just prior to, directly after, as well as 3 and 6 months after Nuss bar removal.
Other: 3D optical surface scan
A 3D optical surface scan is acquired utilizing a handheld 3D scanner. Such a scanner is comparable to an ordinary photo camera, however, it also records depth.
- Mean change in distance [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]The mean distance of thoracic wall changes
- Maximum change in distance [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]The maximum distance of thoracic wall changes
- Volumetric changes [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]The volumetric chest wall changes
- Predictors of chest wall changes [ Time Frame: Changes in volume, mean and maximum distance from baseline to 6 months ]Predictors of chest wall changes, assessed by multivariate analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052321
|Contact: Jean Daemenfirstname.lastname@example.org|
|Zuyderland Medical Centre|
|Heerlen, Limburg, Netherlands, 6419PC|
|Contact: Jean Daemen +31884597777 email@example.com|