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Recruiting NCT07081620

Percutaneous Intercostal Cryoneuromodulation Onset Timing.

Observational Cryotherapy Effect Pectus Excavatum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical examination of chest skin.
Who it may be relevant to
Registry conditions: Cryotherapy Effect, Pectus Excavatum. Basic parameters: 12 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

How Long Does it Take for Percutaneous Intercostal Cryoneuromodulation to Produce Cryoanalgesia? A Prospective Observational Study.

Overview

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.

Interventions

  • Other Physical examination of chest skin
    soft touch and thermal (cold and warm) examination

Primary outcome measures

  • thermal sensitivity [Time frame: one week (median)]
Secondary outcome measures (1)
  • chest skin sensitivity to touch [Time frame: one week (median)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • failure to obtain consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Papa Giovanni XXIII Hospital — Bergamo

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. PMID 39510802

Identifiers

NCT: NCT07081620 · PICOT1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗