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Active, not recruiting Not applicable Interventional

Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

ClinicalTrials.gov ID: NCT06340451

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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 9:14 PM EDT

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
Lead sponsor
Pacira Pharmaceuticals, Inc
Industry
Enrollment
132 participants

Conditions and interventions

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 11, 2024 (Actual)
Primary completion
Oct 2026 (Estimated)
Completion
Oct 2026 (Estimated)
Last update posted
Jul 6, 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 6, 2026 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06340451 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →