Pectus ExcavatumCHESTNCT07498699
Quantifying Changes in the Thoracic Wall After Nuss Bar Removal in Pectus Excavatum Patients Using 3D Imaging
An observational study of Pectus Excavatum, run by Erik de Loos at 1 site in Netherlands.
Trial summary
Pectus excavatum (funnel chest) is the most common congenital anterior thoracic wall deformity. It can be associated not only with cosmetic concerns but also with psychosocial and limiting somatic complaints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pectus Excavatum
- How many people
- 69 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Sep 2020to 6 Jan 2025
- How long will I take part?
- 3 Months
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pectus excavatum who are visit our outpatient clinic and are scheduled for the removal of their Nuss bar.
Who may be able to join
- Patients of all ages and genders with a Nuss bar eligible for removal.
Who cannot join
- Patients in whom the bar or stabilizing components were dislocated
- Patients who underwent a second surgery for their pectus excavatum following the initial placement of the Nuss bar
- Patients in whom retrosternal metal bars have been placed for any indication other than the treatment of pectus excavatum
- Patients with connective tissue disorders such as Marfan syndrome
- Patients diagnosed with epilepsy
- Patients who are unable to maintain a stationary standing position for approximately 60 seconds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Thoracic Wall Changes Using Three-dimensional Optical Imaging After Nuss Bar Removal
Pectus excavatum (funnel chest) is the most common congenital anterior thoracic wall deformity. It can be associated not only with cosmetic concerns but also with psychosocial and limiting somatic complaints. Patients with this condition are often treated surgically using the Nuss bar procedure, in which a metal bar is placed behind the sternum to effectively "pop out" the funnel chest. This bar typically remains in place for 2-3 years.
To analyze how the thoracic wall changes after removal of the Nuss bar, we aim to capture three-dimensional (3D) images at four different time points: just before removal, immediately after, and at 6 and 12 months post-removal. When significant changes over time are detected, we aim to identify factors that may predict retraction or recurrence. Based on these predictive factors, individualized decision-making regarding the timing of Nuss bar removal can be optimized to minimize the risk of retraction or recurrence.
- Conditions
- Pectus Excavatum
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative 3D scans | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
External Haller index
Measured: just before removal, immediately after, and at 6 and 12 months post-removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start16 Sep 2020
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
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
- Prospective
- Enrolment
- 69 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erik de Loos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erik de Loos, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498699
- Sponsor's protocol ID
- Z2019101
- Acronym
- CHEST
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Thoracic Wall Changes Using Three-dimensional Optical Imaging After Nuss Bar Removal
- ClinicalTrials.gov ID
- NCT07498699
- Acronym / sponsor ID
- CHEST / Z2019101
- Conditions
- Pectus Excavatum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Erik de LoosUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 27 Mar 2026 (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 (funnel chest) is the most common congenital anterior thoracic wall deformity. It can be associated not only with cosmetic concerns but also with psychosocial and limiting somatic complaints. Patients with this condition are often treated surgically using the Nuss bar procedure, in which a metal bar is placed behind the sternum to effectively "pop out" the funnel chest. This bar typically remains in place for 2-3 years.
To analyze how the thoracic wall changes after removal of the Nuss bar, we aim to capture three-dimensional (3D) images at four different time points: just before removal, immediately after, and at 6 and 12 months post-removal. When significant changes over time are detected, we aim to identify factors that may predict retraction or recurrence. Based on these predictive factors, individualized decision-making regarding the timing of Nuss bar removal can be optimized to minimize the risk of retraction or recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative 3D scans | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pectus excavatum who are visit our outpatient clinic and are scheduled for the removal of their Nuss bar.
Key inclusion criteria (1 listed)
- Patients of all ages and genders with a Nuss bar eligible for removal.
Key exclusion criteria (6 listed)
- Patients in whom the bar or stabilizing components were dislocated
- Patients who underwent a second surgery for their pectus excavatum following the initial placement of the Nuss bar
- Patients in whom retrosternal metal bars have been placed for any indication other than the treatment of pectus excavatum
- Patients with connective tissue disorders such as Marfan syndrome
- Patients diagnosed with epilepsy
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
External Haller index
Time frame: just before removal, immediately after, and at 6 and 12 months post-removal.
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Pectus Excavatum, run by Erik de Loos 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 6 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 27 Mar 2026. 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?
External Haller index (time frame: just before removal, immediately after, and at 6 and 12 months post-removal.). 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 27 Mar 2026.