Pectus ExcavatumCHESTNCT04052321
Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
A study testing 3D optical surface scan in people with Pectus Excavatum, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- 3D optical surface scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2021to Jan 2022
- 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
- Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.
Who cannot join
- Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
- Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
- Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
- Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
- Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Zuyderland Medical Centre
Heerlen, Limburg, 6419PC
Jean Daemen, +31884597777, j.daemen@zuyderland.nl
About this study
Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.
- Conditions
- Pectus Excavatum
- Being tested
- 3D optical surface scan
- Keywords
- Three-dimensional optical surface imaging, Chest wall changes
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D optical surface scanOther
A 3D optical surface scan is acquired utilizing a handheld 3D scanner. Such a scanner is comparable to an ordinary photo camera, however, it also records depth.
| Study group | Role | What they receive |
|---|---|---|
| 3D scan arm | Experimental | This is a single arm study. Patients in this arm will receive a 3D scan just prior to, 2 weeks after, as well as 6 and 12 months after Nuss bar removal. Receives: Other: 3D optical surface scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in distance
The mean distance of thoracic wall changes
Measured: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Maximum change in distance
The maximum distance of thoracic wall changes
Measured: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Volumetric changes
The volumetric chest wall changes
Measured: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Secondary outcomes (1)
Predictors of chest wall changes
Predictors of chest wall changes, assessed by multivariate analysis.
Measured: Changes in volume, mean and maximum distance from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT04052321
- Sponsor's protocol ID
- METCZ20190103
- Acronym
- CHEST
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gomes-Fonseca J, Vilaca JL, Henriques-Coelho T, Direito-Santos B, Pinho ACM, Fonseca JC, Correia-Pinto J. A new methodology for assessment of pectus excavatum correction after bar removal in Nuss procedure: Preliminary study. J Pediatr Surg. 2017 Jul;52(7):1089-1097. doi: 10.1016/j.jpedsurg.2016.12.029. Epub 2017 Jan 7.
PubMed 28094014
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
- ClinicalTrials.gov ID
- NCT04052321
- Acronym / sponsor ID
- CHEST / METCZ20190103
- Conditions
- Pectus Excavatum
- Keywords
- Three-dimensional optical surface imaging, Chest wall changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 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 that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D scan arm | Experimental | Other: 3D optical surface scanThis is a single arm study. Patients in this arm will receive a 3D scan just prior to, 2 weeks after, as well as 6 and 12 months after Nuss bar removal. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.
Key exclusion criteria (5 listed)
- Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
- Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
- Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
- Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
- Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.
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 |
|---|---|---|
| 3D optical surface scanA 3D optical surface scan is acquired utilizing a handheld 3D scanner. Such a scanner is comparable to an ordinary photo camera, however, it also records depth. | Other | 3D scan arm |
Primary outcome
Mean change in distance
Time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The mean distance of thoracic wall changes
Maximum change in distance
Time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The maximum distance of thoracic wall changes
Volumetric changes
Time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The volumetric chest wall changes
1 secondary outcome
Predictors of chest wall changes
Time frame: Changes in volume, mean and maximum distance from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 28094014Gomes-Fonseca J, Vilaca JL, Henriques-Coelho T, Direito-Santos B, Pinho ACM, Fonseca JC, Correia-Pinto J. A new methodology for assessment of pectus excavatum correction after bar removal in Nuss procedure: Preliminary study. J Pediatr Surg. 2017 Jul;52(7):1089-1097. doi: 10.1016/j.jpedsurg.2016.12.029. Epub 2017 Jan 7.
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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 3D optical surface scan in people with 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 5 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 4 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?
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?
Mean change in distance (time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052321, which also lists 1 linked publication.
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 4 Nov 2020.