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NCT06340451 · ClinicalTrials.gov registry record · NA
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
A NA study of Spasticity, Cerebral or Spinal Condition, sponsored by Pacira Pharmaceuticals.
- Recruiting
- Registry status
- NA
- Development phase
- 132
- Enrollment target
- 18
- Study locations
NCT06340451: Recruiting NA study of Spasticity, Cerebral or Spinal Condition, sponsored by Pacira Pharmaceuticals.
NCT06340451 is a NA study of Spasticity, Cerebral or Spinal Condition that is actively recruiting participants, run by Pacira Pharmaceuticals. The registered enrollment target is 132 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06340451, a NA study of Spasticity, Cerebral or Spinal Condition, is actively recruiting participants, sponsored by Pacira Pharmaceuticals.
- RECRUITING
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
- 18
- Study locations
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 |
What NCT06340451 shows while recruiting
NCT06340451 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
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.
NCT06340451 lists 18 locations in 12 states (California, Florida, Missouri).
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.
What interventions are being tested in trial NCT06340451?
The interventions under investigation include: iovera° system (DEVICE), sham iovera° system treatment (DEVICE).
Who is sponsoring clinical trial NCT06340451?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06340451's enrollment target sits among peer trials
132 729th of 2000 higher than 1,269 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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