Pectus ExcavatumCRANENCT04418583
Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
A study testing Three-dimensional imaging in people with Pectus Excavatum and Funnel Chest, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pectus Excavatum, Funnel Chest
- What is being tested?
- Three-dimensional imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 May 2020to Mar 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medical Centre
Heerlen, Limburg, 6419PC
Jean Daemen, +314597777, j.daemen@zuyderland.nl
About this study
Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.
- Conditions
- Pectus Excavatum, Funnel Chest
- Being tested
- Three-dimensional imaging
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional imagingDiagnostic test
Three-dimensional surface images, acquired by the Artec Leo
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional imaging | Experimental | Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique. Receives: Diagnostic Test: Three-dimensional imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in chest wall dimensions
difference between baseline (first image) and image after application of the Crane technique
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start13 May 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective case-control study wherein participants are their own control
- Masking
- None (open label)
- 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
- NCT04418583
- Sponsor's protocol ID
- METCZ20200071
- Acronym
- CRANE
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 3 Nov 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
- ClinicalTrials.gov ID
- NCT04418583
- Acronym / sponsor ID
- CRANE / METCZ20200071
- Conditions
- Pectus Excavatum, Funnel Chest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Jun 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.
Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective case-control study wherein participants are their own control
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional imaging | Experimental | Diagnostic Test: Three-dimensional imagingParticipants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.
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 imagingThree-dimensional surface images, acquired by the Artec Leo | Diagnostic test | Three-dimensional imaging |
Primary outcome
Mean change in chest wall dimensions
Time frame: 1 hour
difference between baseline (first image) and image after application of the Crane technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
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 imaging in people with Pectus Excavatum and Funnel Chest, 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 3 Nov 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in chest wall dimensions (time frame: 1 hour). 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 3 Nov 2020.