Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum

Pectus Excavatum Clinical Trial

Official title:

Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185870
• Other study ID #: METCZ20190151
• Status: Completed
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: December 2019
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pectus excavatum is the most common congenital anterior chest wall deformity, known to occur in 1:400 of new-borns. Complaints may be of cosmetic nature or as a consequence of (cardio)pulmonary impairment. Part of the current work-up of pectus excavatum patients in Zuyderland Medical Centre (Heerlen, the Netherlands) is visual documentation of the deformity. Visual documentation is performed utilising a single-reflex camera and consists of 5 standard photographs (acquired from different angles) and two specialised recordings. These specialised recordings encompass a recording to measure the pectus excavatum's depth and a raster stereography recording to create a three-dimensional perspective. However, this form of visual documentation is not efficient, as it is time- and labor-intensive for the photographer and patient.

Recently, another study started that aims to investigate whether three-dimensional (3D) optical surface scans can be used to determine pectus severity, as compared to chest radiographs and computed tomography scans (3DPECTUS study; METCZ20190048; NCT03926078). Building on this study it was determined whether 3D optical surface scans can be used as a tool to document the surface geometry of pectus excavatum. To determine whether the current standard photographs and specialised recordings can be replaced by a 3D scan, both methods are compared. To make this comparison, the pectus excavatum depth was chosen as an objective measure of agreement. If there is good agreement, it is assumed that the standard photos can be replaced by a 3D photo in the current work-up. This will subsequently result in a time saving as well as a reduced burden for the patient while acquisition of 3D scans takes only 10 seconds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All participants of the 3D PECTUS study (METCZ20190048; NCT03926078) that received a 3D scan and standard photographies.

Exclusion Criteria:

• Participants in which the photography based pectus excavatum depth was measured in the transversal plane.

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Diagnostic Test:
• 3D scan
All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.
• Standard photography
All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard photography based pectus excavatum depth	The pectus excavatum depth is derived from one of the specialized recordings. The depth is obtained by placing a rigid bar with rule over the most excavated part in the transversal plane.	2 months
Primary	3D scan based pectus excavatum depth	The pectus excavatum depth is calculated by slicing the 3D scan in the longitudinal direction. The pectus depth is subsequently calculated from the transversal slice with the most severe excavation.	2 months
Primary	Absolute agreement between the 3D scan and photography based pectus excavatum depth.	The absolute agreement was assessed by calculation of the intraclass correlation coefficient.	2 months