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RecruitingNCT07081620Updated Jul 23, 2025

Percutaneous Intercostal Cryoneuromodulation Onset Timing.

An observational study in Cryotherapy Effect and Pectus Excavatum, sponsored by Papa Giovanni XXIII Hospital. Recruiting at 1 site in Italy. Open to participants aged 12 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Papa Giovanni XXIII Hospital · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
12 Years to 40 Years
Sex
All
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Study summary

Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.

02

Conditions studied

  • Cryotherapy Effect
  • Pectus Excavatum

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Keywords

  • Cryoneurolysis
  • Cryoneuromodulation
03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 68 across 32 observational studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Papa Giovanni XXIII Hospital is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Mainly adolescents, mainly males

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are undergoing preoperative percutaneous intercostal cryoneurolysis for pectus excavatum surgery

Exclusion criteria

Exclusion Criteria:

  • failure to obtain consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pectus patients

    Patients who are eligible for Nuss procedure (for pectus excavatum correction) are undergoing "earlier preoperative percutaneous intercostal cryoneurolysis" in our institution. They are studied through a physical examination also.

    Other: Physical examination of chest skin

Interventions

  • OtherPhysical examination of chest skin

    soft touch and thermal (cold and warm) examination

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What researchers measure

Primary outcomes

  1. thermal sensitivity

    Chest skin thermal sensitivity will be assessed through a "thermofeel" metal instrument set at two different temperatures: 15°C for cold sensation and 40°C for warm sensation. At least 4 different chest zones will be tested to discriminate potential differences. As a validated instument for chest skin thermal assessment does not exist, we will report only qualitative results, as "normal" "impaired" or "absent" sensitivity.

    Time frame: one week (median)

Secondary outcomes

  1. chest skin sensitivity to touch

    Chest skin mechanical sensitivity will be assessed through both validated von Frey filament testing, and cotton swab for soft touch. At least 4 different chest zones will be tested to discriminate potential differences. We will report qualitative results, as "normal" "impaired" or "absent" sensitivity.

    Time frame: one week (median)

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Study locations

1 of 1 sites recruiting
  • Papa Giovanni XXIII Hospital
    Bergamo, BG 24100, Italy
    Recruiting
    • Stefano Mariconti · Contact
    • Stefano Mariconti, MD · Principal investigator
08

References and documents

Publications

  • Mariconti S, Bronco A, Pellicioli I, Chiudinelli L, Cattaneo M, Cheli M, Bonanomi E. Earlier preoperative percutaneous intercostal cryoanalgesia improves recovery after pectus excavatum surgery. Reg Anesth Pain Med. 2026 Feb 5;51(2):200-207. doi: 10.1136/rapm-2024-105960. PubMed 39510802 ↗

Individual participant data

Plan to share: Undecided — Population basic data

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Sep 2026, 15 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2025
First posted
Jul 23, 2025
StartActual
Jun 7, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Nov 2026
Last update
Jul 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07081620
Lead sponsor
Papa Giovanni XXIII Hospital
Responsible party
Stefano Mariconti (Principal Investigator, Papa Giovanni XXIII Hospital) — Principal investigator
First posted
Jul 23, 2025
Start date
Jun 7, 2025
Primary completion
Sep 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jul 23, 2025

Study contacts

Stefano Mariconti, MD
Contact
smariconti@asst-pg23.it
00390358347

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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