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

PHASE3RecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Spasticity, Cerebral or Spinal Condition
Interventions
DEVICE

iovera° system

subjects will receive ultrasound-guided iovera° system treatment

DEVICE

sham iovera° system treatment

subjects will receive ultrasound-guided iovera° sham system treatment

Trial Locations (18)

15213

RECRUITING

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital, Pittsburgh

19027

RECRUITING

Moss Rehab Physical Medicine Associates, Elkins Park

23238

RECRUITING

Virginia iSpine Physicians, PC, Richmond

30309

RECRUITING

Shepherd Center, Atlanta

34209

RECRUITING

Nova Clinical Research, LLC, Bradenton

53228

RECRUITING

Center for Neurological Disorders - Gamma Therapeutic Center, Greenfield

66211

RECRUITING

Kansas Institute of Research - Kansas City Bone & Joint Clinic, Overland Park

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

University of Texas Health Houston/TIRR, Houston

90242

RECRUITING

Rancho Los Amigos National Rehabilitation Center, Downey

90403

RECRUITING

Source Healthcare - Santa Monica, Santa Monica

99202

RECRUITING

St. Luke's Rehabilitation Institute/Main Campus, Spokane

34239-2921

RECRUITING

Sarasota Memorial Hospital (SMH), Sarasota

65212-0001

RECRUITING

University of Missouri Health Care - University Hospital, Columbia

63110-1032

RECRUITING

Washington University School of Medicine, St Louis

08103

RECRUITING

Cooper University Healthcare, Camden

10029-6501

RECRUITING

Mount Sinai Health System - Faculty Practice Associates (FPA), New York

53226-3548

RECRUITING

Froedtert and Medical College of Wisconsin - Milwaukee, Milwaukee

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY

NCT06340451 - Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity | Biotech Hunter | Biotech Hunter