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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 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. The trial reports 18 study locations across 12 states.
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 |
Interested in This Trial?
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, categorized as NA. 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 88 total studies on file at ClinicalTrials.gov.
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 reports 18 study locations spanning 12 distinct geographic areas - top geographies include 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.
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