Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340451
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-25
Brief Title:
Study to Assess the Efficacy and Safety of Iovera System in Subjects with Upper Extremity Spasticity
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
Pacira Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Sham-Controlled Study Assessing the Efficacy and Safety of Iovera System in Subjects with Upper Extremity Spasticity
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The screening and treatment may occur on the same day or be separated by as much as 30 days All screening procedures must be completed and criteria must be met before a subject is randomly assigned in the study After random allocation to treatment the subject will be scheduled for treatment Day 1
For all subjects a Baseline Day 1 pretreatment Modified Ashworth Scale MAS score Modified Tardieu Scale and Goal Attainment Scale GAS score will be assessed and recorded before treatment on Day 1 treatment day
On Day 1 treatment day subjects will be reassessed for eligibility and randomly assigned in a blinded fashion 21 to receive either the iovera system treatment or sham treatment The study device will be used per the iovera system User Guide on subjects who are prepared with local anesthetic lidocaine 1 only
Local anesthetic will be injected subcutaneously into the treatment area Ultrasound guidance will then be used to identify the specific target nerves to be studied The targets of treatment are the medial and lateral pectoral nerves and musculocutaneous nerve motor branches to brachialis and biceps brachii A catheter will be used to guide the device needle All subjects will have all target nerves treated Nerve stimulation will also be employed as needed to assist in making an accurate determination regarding the location of the target nerves of interest Up to two unblinded 1 primary and 1 backup study staff trained in the iovera system treatment under ultrasound guidance will be assigned per site to perform the study treatment procedures unless approved in advance in writing by the Sponsor on a case-by-case basis The designated unblinded study staff must not participate in any other study-related assessments following treatment
Each subject will be followed for 13 weeks post-treatment The follow-up visits will be conducted at Week 3Day 21 3 Week 7Day 49 3 and Week 13Day 91 5 Subjects will be assessed for efficacy and safety outcomes parameters
For all subjects a Baseline Day 1 pretreatment Modified Ashworth Scale MAS score Modified Tardieu Scale and Goal Attainment Scale GAS score will be assessed and recorded before treatment on Day 1 treatment day
On Day 1 treatment day subjects will be reassessed for eligibility and randomly assigned in a blinded fashion 21 to receive either the iovera system treatment or sham treatment The study device will be used per the iovera system User Guide on subjects who are prepared with local anesthetic lidocaine 1 only
Local anesthetic will be injected subcutaneously into the treatment area Ultrasound guidance will then be used to identify the specific target nerves to be studied The targets of treatment are the medial and lateral pectoral nerves and musculocutaneous nerve motor branches to brachialis and biceps brachii A catheter will be used to guide the device needle All subjects will have all target nerves treated Nerve stimulation will also be employed as needed to assist in making an accurate determination regarding the location of the target nerves of interest Up to two unblinded 1 primary and 1 backup study staff trained in the iovera system treatment under ultrasound guidance will be assigned per site to perform the study treatment procedures unless approved in advance in writing by the Sponsor on a case-by-case basis The designated unblinded study staff must not participate in any other study-related assessments following treatment
Each subject will be followed for 13 weeks post-treatment The follow-up visits will be conducted at Week 3Day 21 3 Week 7Day 49 3 and Week 13Day 91 5 Subjects will be assessed for efficacy and safety outcomes parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None