Trials / Active Not Recruiting
Active Not RecruitingNCT06700109
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE
INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE: A MULTI-CENTER, RANDOMIZED, CONTROLLED STUDY (ICE STUDY)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 263 (estimated)
- Sponsor
- Brixton Biosciences, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate the effectiveness of Neural Ice for pain management associated with knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neural Ice | This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves. |
| DRUG | Triamcinolone acetate | A single dose of Triamcinolone 40mg injected directly into the joint space. |
Timeline
- Start date
- 2024-11-19
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2024-11-21
- Last updated
- 2025-10-28
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06700109. Inclusion in this directory is not an endorsement.