Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
Public ClinicalTrials.gov record NCT06340451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).
Study identification
- NCT ID
- NCT06340451
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 10, 2024
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
- Last update posted
- Jul 5, 2026
2024 – 2026
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rancho Los Amigos National Rehabilitation Center | Downey | California | 90242 | — |
| Source Healthcare - Santa Monica | Santa Monica | California | 90403 | — |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | — |
| Sarasota Memorial Hospital (SMH) | Sarasota | Florida | 34239-2921 | — |
| Shepherd Center | Atlanta | Georgia | 30309 | — |
| Kansas Institute of Research - Kansas City Bone & Joint Clinic | Overland Park | Kansas | 66211 | — |
| University of Missouri Health Care - University Hospital | Columbia | Missouri | 65212-0001 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110-1032 | — |
| Cooper University Healthcare | Camden | New Jersey | 08103 | — |
| Mount Sinai Health System - Faculty Practice Associates (FPA) | New York | New York | 10029-6501 | — |
| Moss Rehab Physical Medicine Associates | Elkins Park | Pennsylvania | 19027 | — |
| University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Texas Health Houston/TIRR | Houston | Texas | 77030 | — |
| Virginia iSpine Physicians, PC | Richmond | Virginia | 23238 | — |
| St. Luke's Rehabilitation Institute/Main Campus | Spokane | Washington | 99202 | — |
| Center for Neurological Disorders - Gamma Therapeutic Center | Greenfield | Wisconsin | 53228 | — |
| Froedtert and Medical College of Wisconsin - Milwaukee | Milwaukee | Wisconsin | 53226-3548 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06340451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06340451 live on ClinicalTrials.gov.