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Cryoneurolysis (active) for Below Knee Amputation
N/A
Waitlist Available
Led By Brian Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, and 12
Awards & highlights
Study Summary
This trial is testing if adding cryoanalgesia ( freezing the area around the surgery site) to standard pain relief care can decrease the severity and incidence of post-surgical pain, and improve postoperative functioning.
Eligible Conditions
- Above Knee Amputation
- Below Knee Amputation
- Mastectomy
- Shoulder Replacement Surgery
- Knee Arthritis
- Rotator Cuff Repair
- Elbow Amputation
- Skin Grafting
- Video-assisted Thoracoscopic Surgery
- Below Elbow Amputation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 1, 3, 6, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Pain (Mastectomy Subjects Only)
Secondary outcome measures
Analgesic Consumption
Average Pain Measured on the 11 Point Numeric Rating Scale
Brief Pain Inventory (Interference Subscale)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment (active cryoneurolysis)Experimental Treatment1 Intervention
Receiving active cryoneurolysis
Group II: ShamPlacebo Group1 Intervention
Receiving sham cryoneurolysis procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoneurolysis (active)
2018
N/A
~100
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,308 Total Patients Enrolled
Epimed InternationalUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Myoscience (prior to merger with Pacira Pharmaceuticals)UNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research study ongoing?
"According to the clinicaltrials.gov database, this particular trial is no longer actively looking for participants. The research was initially posted on August 25th 2018 and last edited on August 29th 2022. Nevertheless, there are still 554 other studies with open recruitment at the present time."
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