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

NCT ID: NCT04185870

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-01-02

Brief Summary

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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.

Detailed Description

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Conditions

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Pectus Excavatum Funnel Chest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive standard photographs and a 3D scan
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3D scan and standard photography arm

All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum. In addition, all participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

Group Type EXPERIMENTAL

3D scan

Intervention Type DIAGNOSTIC_TEST

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

Standard photography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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3D scan

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

Intervention Type DIAGNOSTIC_TEST

Standard photography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zuyderland Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zuyderland Medical Centre

Heerlen, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Daemen JHT, Loonen TGJ, Coorens NA, Maessen JG, Maal TJJ, Hulsewe KWE, Vissers YLJ, de Loos ER. Photographic documentation and severity quantification of pectus excavatum through three-dimensional optical surface imaging. J Vis Commun Med. 2020 Oct;43(4):190-197. doi: 10.1080/17453054.2020.1784711. Epub 2020 Aug 14.

Reference Type DERIVED
PMID: 32791868 (View on PubMed)

Other Identifiers

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METCZ20190151

Identifier Type: -

Identifier Source: org_study_id

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