Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
NCT06340451 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DEVICE iovera° system
- DEVICE sham iovera° system treatment
Study Locations (18)
California
- Rancho Los Amigos National Rehabilitation Center — Downey
- Source Healthcare - Santa Monica — Santa Monica
Florida
- Nova Clinical Research, LLC — Bradenton
- Sarasota Memorial Hospital (SMH) — Sarasota
Missouri
- University of Missouri Health Care - University Hospital — Columbia
- Washington University School of Medicine — St Louis
Pennsylvania
- Moss Rehab Physical Medicine Associates — Elkins Park
- University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital — Pittsburgh
Texas
- University of Texas Southwestern Medical Center — Dallas
- University of Texas Health Houston/TIRR — Houston
Wisconsin
- Center for Neurological Disorders - Gamma Therapeutic Center — Greenfield
- Froedtert and Medical College of Wisconsin - Milwaukee — Milwaukee
Georgia
- Shepherd Center — Atlanta
Kansas
- Kansas Institute of Research - Kansas City Bone & Joint Clinic — Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2026-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06340451
The ClinicalTrials.gov registry entry for NCT06340451 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Spasticity, Cerebral or Spinal Condition appearing as the primary indexed condition, and to 2 interventions — of which iovera° system is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06340451 reports 18 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06340451 about?
NCT06340451 is a clinical study titled "Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity". 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 ...
What is the current status of trial NCT06340451?
This trial is currently recruiting. It is a NA study. The enrollment target is 132 participants. The study started on 2024-07-11. Estimated completion is 2026-03.
What conditions does trial NCT06340451 study?
This clinical trial studies the following conditions: Spasticity, Cerebral or Spinal Condition. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06340451?
The interventions under investigation include: iovera° system (DEVICE), sham iovera° system treatment (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06340451?
This trial is sponsored by Pacira Pharmaceuticals, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06340451 being conducted?
This trial has 18 study locations across California, Florida, Georgia, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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