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

Primary Purpose

Pectus Excavatum, Funnel Chest

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
3D scan
Standard photography
Sponsored by
Zuyderland Medisch Centrum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pectus Excavatum

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zuyderland Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D scan and standard photography arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Absolute agreement between the 3D scan and photography based pectus excavatum depth.
The absolute agreement was assessed by calculation of the intraclass correlation coefficient.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2019
Last Updated
January 7, 2020
Sponsor
Zuyderland Medisch Centrum
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1. Study Identification

Unique Protocol Identification Number
NCT04185870
Brief Title
Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
Official Title
Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zuyderland Medisch Centrum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Funnel Chest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive standard photographs and a 3D scan
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D scan and standard photography arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D scan
Intervention Description
All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard photography
Intervention Description
All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.
Primary Outcome Measure Information:
Title
Standard photography based pectus excavatum depth
Description
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.
Time Frame
2 months
Title
3D scan based pectus excavatum depth
Description
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.
Time Frame
2 months
Title
Absolute agreement between the 3D scan and photography based pectus excavatum depth.
Description
The absolute agreement was assessed by calculation of the intraclass correlation coefficient.
Time Frame
2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Zuyderland Medical Centre
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419PC
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32791868
Citation
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.
Results Reference
derived

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

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