Quantifying Changes in the Thoracic Wall After Nuss Bar Removal in Pectus Excavatum Patients Usin… (NCT07498699) | Clinical Trial Compass
CompletedNot Applicable
Quantifying Changes in the Thoracic Wall After Nuss Bar Removal in Pectus Excavatum Patients Using 3D Imaging
Netherlands69 participantsStarted 2020-09-16
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of all ages and genders with a Nuss bar eligible for removal.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
External Haller index
Timeframe: just before removal, immediately after, and at 6 and 12 months post-removal.