Iovera for Osteoarthritis

N/A

Waitlist Available

Led By Neil A Segal, MD

Research Sponsored by University of Kansas Medical Center

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 change between baseline/screening and 24-weeks following treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment that freezes specific nerves in the ankle to reduce pain in patients with moderate to severe arthritis. The goal is to see if this method provides lasting pain relief and improves quality of life.

Eligible Conditions

Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline/screening and 24-weeks following treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline/screening and 24-weeks following treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline/screening and 24-weeks following treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

FAOS - ADL(Activity of Daily Living)

FAOS - PAIN

FAOS-QoL(Quality of Life)

+1 more

Other study objectives

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 12-weeks Following Treatment

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 24-weeks Following Treatment

Change in 40m Fast Paced Walking Test (40m FPWT) Time Between Baseline/Screening and 6-weeks Following Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IoveraExperimental Treatment1 Intervention

The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iovera

2013

N/A

~130

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