Cryoneurolysis for Rib Fractures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rib Fractures+1 More
Cryoneurolysis - Radiation
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a long-term pain control method for elderly patients with rib fractures. The goal is to help them heal without complications and return to their normal level of function.

Eligible Conditions
  • Rib Fractures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 12 months

1 month
30-day mortality
30-day rib-specific readmission
Number of participants requiring ICU admission
12 months
Acute Pain Assessed by Numeric Pain Score
Short Form (SF-12) Health Survey Scale Score
The Glasgow Outcome Scale Extended (GOS-E) Score
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score
Use of Narcotic Equivalents
Up to 1 month
Length of hospital stay

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard-of Care : Group B
1 of 2
Image-guided percutaneous ICN (pICN): Group A
1 of 2
Active Control
Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Cryoneurolysis · No Placebo Group · N/A

Image-guided percutaneous ICN (pICN): Group A
Radiation
Experimental Group · 1 Intervention: Cryoneurolysis · Intervention Types: Radiation
Standard-of Care : Group B
Other
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoneurolysis
2018
N/A
~150

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,678,894 Total Patients Enrolled
5 Trials studying Rib Fractures
399 Patients Enrolled for Rib Fractures
Nishita Kothary, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Joseph D Forrester, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rib Fractures
40 Patients Enrolled for Rib Fractures

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have a GCS score of < 13.
The patient is unfit for cryoablation due to other factors.
You do not have any rib fractures of ribs 3,4,5,6,7,8, or 9.
Patients undergoing Surgical Stabilization of Rib Fractures (SSRF) are 18 years or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References