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

Sponsor
Zuyderland Medisch Centrum (Other)
Overall Status
Completed
CT.gov ID
NCT04185870
Collaborator
(none)
19
1
1
13
44.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3D scan
  • Diagnostic Test: Standard photography
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive standard photographs and a 3D scanAll participants will receive standard photographs and a 3D scan
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
Actual Study Start Date :
Dec 20, 2019
Actual Primary Completion Date :
Jan 2, 2020
Actual Study Completion Date :
Jan 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

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.

Outcome Measures

Primary Outcome Measures

  1. Standard photography based pectus excavatum depth [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 [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. [2 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zuyderland Medical Centre Heerlen Limburg Netherlands 6419PC

Sponsors and Collaborators

  • Zuyderland Medisch Centrum

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier:
NCT04185870
Other Study ID Numbers:
  • METCZ20190151
First Posted:
Dec 4, 2019
Last Update Posted:
Jan 13, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2020