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OpenTrials
Completed

NCT Number: NCT04185870

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D scan

Diagnostic Test

All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.

Standard photography

Diagnostic Test

All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

Primary outcomes

  1. Standard photography based pectus excavatum depth

    Time frame: 2 months

    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. 3D scan based pectus excavatum depth

    Time frame: 2 months

    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.

  3. Absolute agreement between the 3D scan and photography based pectus excavatum depth.

    Time frame: 2 months

    The absolute agreement was assessed by calculation of the intraclass correlation coefficient.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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