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Cryoneurolysis

Cryoneurolysis for Rib Fractures

N/A

Recruiting

Led By Ara Ko, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 18 to 64 years with any acute rib fracture

Any acute rib fracture between rib 3 and rib 9

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test the effectiveness of using the Iovera Smart Tip 190 to provide pain control for patients with rib fractures.

Who is the study for?

This trial is for adults aged 18-64 who have arrived at Stanford Emergency Department with acute rib fractures and are experiencing significant pain (pain score ≥5) during deep breaths. It's specifically for those with fractures between ribs 3 to 9, not undergoing surgical stabilization, without metastasis to the ribs, no severe coagulopathy or low consciousness level.Check my eligibility

What is being tested?

The study tests the effectiveness of a device called Iovera Smart Tip 190 for cryoneurolysis on intercostal nerves in trauma patients with rib fractures. This non-surgical treatment aims to control pain while the ribs heal. Participants will receive this intervention alongside standard care.See study design

What are the potential side effects?

Potential side effects from cryoneurolysis may include localized numbness, skin irritation or bruising around the treated area, temporary increase in pain before it decreases, and rare risks associated with nerve treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old and have a recent rib fracture.

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I have a recent fracture in one of my middle ribs.

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I experience significant pain when taking a deep breath.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily Narcotic Equivalents

Daily Numeric Pain Score

Length of hospital stay

Secondary outcome measures

30-day mortality

30-day rib-specific admission

Need for ICU admission

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound-guided Cryoneurolysis: Group AExperimental Treatment1 Intervention

Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED. Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190

Group II: Standard-of-Care : Group BActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,400 Previous Clinical Trials

17,341,789 Total Patients Enrolled

5 Trials studying Rib Fractures

310 Patients Enrolled for Rib Fractures

Ara Ko, MDPrincipal InvestigatorStanford University

Joseph D Forrester, MDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

110 Total Patients Enrolled

1 Trials studying Rib Fractures

110 Patients Enrolled for Rib Fractures

Media Library

Iovera Smart Time 190 (Cryoneurolysis) Clinical Trial Eligibility Overview. Trial Name: NCT05330611 — N/A

Rib Fractures Research Study Groups: Standard-of-Care : Group B, Ultrasound-guided Cryoneurolysis: Group A

Rib Fractures Clinical Trial 2023: Iovera Smart Time 190 Highlights & Side Effects. Trial Name: NCT05330611 — N/A

Iovera Smart Time 190 (Cryoneurolysis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05330611 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment for this trial limited to patients aged fifty or younger?

"Based on the stated prerequisites, this medical trial requires all participants to be aged 18 or above and 64 or below."

Answered by AI

To whom is enrollment in this experiment available?

"This clinical study is recruiting 40 individuals who have experienced rib fractures and are aged between 18 to 64 years old."

Answered by AI

What are the aims of this medical research?

"The primary goal of this 12-month trial is to measure Length of hospital stay. Secondary objectives include the rate of ICU admissions, 30-day readmission related to rib injuries such as hemothorax and pneumonia, and patients' pain levels using the McGill Pain Questionnaire (MPQ) and a Pain Rating Index (PRI). The MPQ's 20 questions will be administered by study staff upon discharge with higher PRI scores indicating greater discomfort."

Answered by AI

Is enrollment in this clinical trial open at the moment?

"As per the information posted on clinicaltrials.gov, this specific trial is not currently admitting patients. The initial posting was made in September of 2023 and the most recent edit took place in October 2022 – yet 353 other trials are still actively searching for participants."

Answered by AI

Recent research and studies

Journal of Surgical ResearchJournal

Comparing Outcomes with Thoracic Epidural and Intercostal Nerve Cryoablation After Nuss Procedure

Harbaugh, Calista M., Kevin N. Johnson, Courtney E. Kein, Marcus D. Jarboe, Ronald B. Hirschl, James D. Geiger, and Samir K. Gadepalli. 2018. “Comparing Outcomes with Thoracic Epidural and Intercostal Nerve Cryoablation After Nuss Procedure”. Journal of Surgical Research. Elsevier BV. doi:10.1016/j.jss.2018.05.048.

Trauma Case ReportsJournal

Intercostal Nerve Cryoablation for Control of Traumatic Rib Fracture Pain: A Case Report

Vossler, John D., and Frank Z. Zhao. 2019. “Intercostal Nerve Cryoablation for Control of Traumatic Rib Fracture Pain: A Case Report”. Trauma Case Reports. Elsevier BV. doi:10.1016/j.tcr.2019.100229.

Journal of Pediatric SurgeryJournal

Intercostal Nerve Cryoablation Versus Thoracic Epidural Catheters for Postoperative Analgesia Following Pectus Excavatum Repair: Preliminary Outcomes in Twenty-six Cryoablation Patients

Keller, Benjamin A., Sandra K. Kabagambe, James C. Becker, Y. Julia Chen, Laura F. Goodman, Julianna M. Clark-Wronski, Kenneth Furukawa, et al.. 2016. “Intercostal Nerve Cryoablation Versus Thoracic Epidural Catheters for Postoperative Analgesia Following Pectus Excavatum Repair: Preliminary Outcomes in Twenty-six Cryoablation Patients”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2016.09.034.

InjuryJournal