Pectus ExcavatumPOSITIONNCT04046835
The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum
An observational study of Pectus Excavatum, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2021to Apr 2021
- Phase
- Observational
- 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
Study population: Patients that received a three-dimensional optical surface scan to quatify their pectus deformity utilizing the external Haller Index. Patients were retrospectively recruited from the 3DPECTUS study (METCZ20190048; NCT03926078).
Who may be able to join
- Patients that received a three-dimensional optical surface scan to quantify their pectus deformity
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.
- Conditions
- Pectus Excavatum
- Keywords
- Three-dimensional optical surface scanning, Patient position
- Medical subject headings
- Funnel Chest
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient position
The effect of patient position on the value of the external Haller Index, based on 3D scans.
Measured: 5 months
Secondary outcomes (1)
Manual versus automatic alignment of patient position
If there is a significant effect of patient position on the external Haller Index, the ideal correction method is investigated (manual alignment versus automatic, computer-based alignment)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study startJan 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046835
- Sponsor's protocol ID
- METCZ20190106
- Acronym
- POSITION
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2019
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- The Effect of Patient Position on the External Haller Index Value Among Patients With Pectus Excavatum
- ClinicalTrials.gov ID
- NCT04046835
- Acronym / sponsor ID
- POSITION / METCZ20190106
- Conditions
- Pectus Excavatum
- Keywords
- Three-dimensional optical surface scanning, Patient position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 6 Aug 2019 (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.
Pectus excavatum is the most common anterior chest wall deformity, affecting up to 1:400 of newborns. The current gold standard to quantify the extent of deformity is by calculating the Haller Index based on a Computed Tomography (CT)-scan. However, as such scans inescapably imply exposure to ionizing radiation, novel imaging techniques have been investigated. Three-dimensional optical surface scanning is a promising new technique to acquire the trunks' three-dimensional (3D) surface topography. Based on this 3D scan, one is able to calculate the external Haller Index that is known to highly correlate with the conventional gold standard Haller Index that is based on internal measures. Both the conventional and external Haller Index are known to be affected by the respiratory phase in which the scan is acquired, however, what is the effect of patient position on the external Haller Index, and if affected, how should one correct for this phenomenon? To investigate this, a retrospective single-centre pilot study will be conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that received a three-dimensional optical surface scan to quatify their pectus deformity utilizing the external Haller Index. Patients were retrospectively recruited from the 3DPECTUS study (METCZ20190048; NCT03926078).
Key inclusion criteria (1 listed)
- Patients that received a three-dimensional optical surface scan to quantify their pectus deformity
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.
Primary outcome
Patient position
Time frame: 5 months
The effect of patient position on the value of the external Haller Index, based on 3D scans.
1 secondary outcome
Manual versus automatic alignment of patient position
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pectus Excavatum, 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Daemen (+31884597777, j.daemen@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient position (time frame: 5 months). 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.