Long-term safety follow-up after freezing nerves to help pain after chest surgery
Official title: Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis: Neuropathic Pain, Quality of Life and Sensory Recovery in a Paediatric Cohort Following Pectus Excavatum Repair
Run by Papa Giovanni XXIII Hospital · NCT07657845 · Data updated 2026-11-12
This study follow-ups patients who had percutaneous cryoneurolysis to help pain after Nuss procedure for pectus excavatum and checks their pain, nerve sensations, and quality of life over up to 24 months.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Papa Giovanni XXIII Hospital Academic / other |
| Locations | 1 site (Bergamo, BG) |
| Status | Recruiting |
| Started | February 2, 2025 |
| Main results expected | June 13, 2026 |
| Study ends | January 15, 2029 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07657845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 14 or older who had percutaneous cryoneurolysis in conjunction with Nuss procedure for pectus excavatum and are willing to complete follow-up visits and questionnaires.
✕Probably not a fit
Patients who do not experience neuropathic symptoms or chronic pain changes, or who miss follow-up visits, may not demonstrate a clear benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study tracks patients who received percutaneous cryoneurolysis for pain control after pectus excavatum repair with the Nuss procedure. Participants undergo physical exams and neurosensory assessments at 1, 3, 6, 12, and 24 months postoperatively, along with validated questionnaires to measure neuropathic and chronic pain and overall quality of life. Interventions include the LANSS questionnaire, the Pediatric Quality of Life Inventory (PedsQL), and a self-assessment sensory scale. The study aims to document long-term safety and patient-reported outcomes related to neuropathic symptoms, chronic pain, and life impact. Only patients who had the procedure and provide informed consent are eligible, with follow-up adherence as a key requirement.
Why it matters
Potential benefit: If successful, the study could clarify long-term safety and how sustained nerve freezing affects pain and quality of life after chest-wall surgery.
How similar studies have gone: Prior work in similar nerve-targeting pain interventions has shown mixed results; this study adds long-term observational data for this specific application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who underwent percutaneous cryoneurolysis. * Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure. * Signed informed consent. Exclusion Criteria: * Refusal to participate in the study * Peripheral nervous system disorders * Age \< 14 years * Failure to attend scheduled follow-up visits
Where it's running
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ASST Papa Giovanni XXIII
Bergamo, Bg, Italy Recruiting
Study contacts
- Study coordinator: Stefano Mariconti, MD
- Email: smariconti@asst-pg23.it
- Phone: 0039 + 0352675149
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.