Cryo AnalgesiaCRYOFUPNCT07657845
Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis
An observational study of Cryo Analgesia and Pectus Surgery, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cryo Analgesia, Pectus Surgery
- What is being tested?
- Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2025to 15 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.
Who may be able to join
- Patients who underwent percutaneous cryoneurolysis.
- Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
- Signed informed consent.
Who cannot join
- Refusal to participate in the study
- Peripheral nervous system disorders
- Age < 14 years
- Failure to attend scheduled follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo, BG, 24127
Stefano Mariconti, MD, 0039 + 0352675149, smariconti@asst-pg23.it
About this study
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
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management
Read the detailed description
Follow up of patients after receiving percutaneous cryoneurolysis for pectus excavatum repair, who undergo a physical examination and a neurosensory assessment of the chest wall at 1, 3, 6, 12, and 24 months postoperatively, corresponding to the scheduled follow-up visits. In addition, to evaluate neuropathic pain, chronic pain, and quality of life, patients complete validated questionnaires.
- Conditions
- Cryo Analgesia, Pectus Surgery
- Being tested
- Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale
- Keywords
- follow up, lanss, neuropathy, chronic pain, cpsp, neuropathic pain, sensitivity recovery, PedsQL
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory ScaleDiagnostic test
Assessment tools include validated questionnaires - the S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs, range 0-24, higher scores indicating greater likelihood of neuropathic pain) and the PedsQL™ (Pediatric Quality of Life Inventory, v4.0, Adolescent/Young Adult Report, range 0-100, higher scores indicating better health-related quality of life) - together with the Patient Self-Assessment Sensory Scale (range 0-10, 0 indicating no sensitivity and 10 indicating normal sensitivity) and a structured physical examination of thoracic sensitivity. These tools are administered at pre-specified follow-up timepoints. The physical examination assesses four sensory modalities corresponding to specific afferent fibre classes of the intercostal nerves: cold thermal sensation (Aδ fibres, ice-water contact, 4-10°C), warm thermal sensation (C fibres, ~40°C water), light touch (Aβ fibres, camel-hair brush), and pressure sensitivity (Aβ fibres, Von Frey filament 5.07/10g)
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management | All patients who underwent surgical correction of pectus excavatum via the Nuss procedure between July 1, 2022 and February 28, 2026 are considered eligible for enrollment. Additionally, for the prospective component, patients scheduled for surgery up to December 31, 2026 at the Pediatric Surgery department of our institution will be considered eligible.
Inclusion criteria:
Age greater than 14 years. Patients who underwent percutaneous cryoneurolysis. Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
Exclusion criteria:
Patients who withhold consent to participate in the study, patients with pre-existing neurological conditions, and patients who do not attend the scheduled follow-up visits will be excluded from the study. Receives: Diagnostic Test: Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
To assess the incidence of neuropathic pain using the validated S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs) scale, administered at the scheduled follow-up visits. The S-LANSS score ranges from 0 to 24, with higher scores indicating greater likelihood and severity of neuropathic pain (a score ≥12 is suggestive of pain of predominantly neuropathic origin
Measured: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
Secondary outcomes (3)
Pediatric Quality of Life Inventory (PedsQL) questionnaire
To describe the quality of life of patients using a specific validated questionnaire appropriate for adolescents and young adults (Pediatric Quality of Life Inventory - PedsQL™ version 4.0 for adolescents and young adults). The PedsQL total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
chronic postoperative pain (CPSP) assessment
To describe the incidence of chronic postoperative pain (CPSP), defined as persistence of pain beyond one month, according to two parameters: direct measurement using the NRS (Numeric Rating Scale) for pain intensity, and indirect measurement through consumption of analgesic medications included in the institutional current protocol (acetaminophen and NSAIDs). The NRS ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
Measured: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
sensitivity recovery using the Patient Self-Assessment Sensory Scale
To describe the evolution of thoracic thermotactile hypoesthesia over time, starting from the day of cryoneurolysis, using the Patient Self-Assessment Sensory Scale. The scale ranges from 0 to 10, with 0 indicating no sensitivity (complete anaesthesia) and 10 indicating maximal/normal sensitivity, with higher scores indicating better (more complete) sensory recovery.
Measured: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start2 Feb 2025
- Primary completion13 Jun 2026
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryo AnalgesiaStudies 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Mariconti, Papa Giovanni XXIII Hospital
- Investigators
- Ezio Bonanomi, MD, Study chair, Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657845
- Sponsor's protocol ID
- CRYOFUP
- Acronym
- CRYOFUP
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07657845
- Acronym / sponsor ID
- CRYOFUP / CRYOFUP
- Conditions
- Cryo Analgesia, Pectus Surgery
- Keywords
- follow up, lanss, neuropathy, chronic pain, cpsp, neuropathic pain, sensitivity recovery, PedsQL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 13 Jun 2026 (actual)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 18 Jun 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.
Follow up of patients who underwent percutaneous cryoneurolysis for pectus excavatum repair (the Nuss procedure) pain management
Detailed description
Follow up of patients after receiving percutaneous cryoneurolysis for pectus excavatum repair, who undergo a physical examination and a neurosensory assessment of the chest wall at 1, 3, 6, 12, and 24 months postoperatively, corresponding to the scheduled follow-up visits. In addition, to evaluate neuropathic pain, chronic pain, and quality of life, patients complete validated questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management | – | Diagnostic Test: Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory ScaleAll patients who underwent surgical correction of pectus excavatum via the Nuss procedure between July 1, 2022 and February 28, 2026 are considered eligible for enrollment. Additionally, for the prospective component, patients scheduled for surgery up to December 31, 2026 at the Pediatric Surgery department of our institution will be considered eligible. Inclusion criteria: Age greater than 14 years. Patients who underwent percutaneous cryoneurolysis. Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure. Exclusion criteria: Patients who withhold consent to participate in the study, patients with pre-existing neurological conditions, and patients who do not attend the scheduled follow-up visits will be excluded from the study. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents older than 14 years and young adults who underwent percutaneous cryoanalgesia between July 1, 2022 and December 31, 2026.
Key inclusion criteria (3 listed)
- Patients who underwent percutaneous cryoneurolysis.
- Patients who underwent surgical correction of pectus excavatum according to the Nuss procedure.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Peripheral nervous system disorders
- Age < 14 years
- Failure to attend scheduled follow-up visits
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 |
|---|---|---|
| Self-report Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Questionnaire - Pediatric Quality of Life Inventory (PedsQL™) Questionnaire - Patient Self-Assessment Sensory ScaleAssessment tools include validated questionnaires - the S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs, range 0-24, higher scores indicating greater likelihood of neuropathic pain) and the PedsQL™ (Pediatric Quality of Life Inventory, v4.0, Adolescent/Young Adult Report, range 0-100, higher scores indicating better health-related quality of life) - together with the Patient Self-Assessment Sensory Scale (range 0-10, 0 indicating no sensitivity and 10 indicating normal sensitivity) and a structured physical examination of thoracic sensitivity. These tools are administered at pre-specified follow-up timepoints. The physical examination assesses four sensory modalities corresponding to specific afferent fibre classes of the intercostal nerves: cold thermal sensation (Aδ fibres, ice-water contact, 4-10°C), warm thermal sensation (C fibres, ~40°C water), light touch (Aβ fibres, camel-hair brush), and pressure sensitivity (Aβ fibres, Von Frey filament 5.07/10g) | Diagnostic test | Patients who underwent percutaneous cryoneurolysis for the Nuss procedure pain management |
Primary outcome
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results
Time frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.
To assess the incidence of neuropathic pain using the validated S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs) scale, administered at the scheduled follow-up visits. The S-LANSS score ranges from 0 to 24, with higher scores indicating greater likelihood and severity of neuropathic pain (a score ≥12 is suggestive of pain of predominantly neuropathic origin
3 secondary outcomes
Pediatric Quality of Life Inventory (PedsQL) questionnaire
Time frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how quality of life evolve over time.
chronic postoperative pain (CPSP) assessment
Time frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how chronic pain evolve over time.
sensitivity recovery using the Patient Self-Assessment Sensory Scale
Time frame: The same patients are assessed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how sensitivity recovery evolve over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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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.
Ezio Bonanomi, MD study chair
Department of Anesthesia and Intensive Care, Paediatric Anesthesiology and Intensive Care Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
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 Cryo Analgesia and Pectus Surgery, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Mariconti, MD (0039 + 0352675149, smariconti@asst-pg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire results (time frame: The same patients are followed across multiple timepoints (1, 3, 6, 12, 24 months), allowing to track how S-LANSS score evolve over time.). 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 22 Jun 2026.