Chest Wall DisorderNCT04279886
Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities
A study testing Three-dimensional scans in people with Chest Wall Disorder, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chest Wall Disorder
- What is being tested?
- Three-dimensional scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Feb 2020to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers only
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility.
The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.
- Conditions
- Chest Wall Disorder
- Being tested
- Three-dimensional scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional scansOther
All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional scan arm | Other | Not described Receives: Other: Three-dimensional scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility
Mean difference between subsequent scans utilizing the same three-dimensional scanning system
Measured: 1 month
Accuracy
Mean difference between scans, acquired by different three-dimensional scanning systems
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start20 Feb 2020
- Primary completion20 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279886
- Sponsor's protocol ID
- 2020-6130
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities
- ClinicalTrials.gov ID
- NCT04279886
- Acronym / sponsor ID
- 2020-6130
- Conditions
- Chest Wall Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility.
The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional scan arm | Other | Other: Three-dimensional scans |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers only
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional scansAll included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system) | Other | Three-dimensional scan arm |
Primary outcome
Reproducibility
Time frame: 1 month
Mean difference between subsequent scans utilizing the same three-dimensional scanning system
Accuracy
Time frame: 1 month
Mean difference between scans, acquired by different three-dimensional scanning systems
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-dimensional scans in people with Chest Wall Disorder, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.