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Interventional Arm for Pain (STIMFIX Trial)
N/A
Recruiting
Led By Phillip Lim, DO, MPH
Research Sponsored by STIMFIX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days or depending on the post trial period (per standard of care)
Awards & highlights
STIMFIX Trial Summary
This trial will study the effectiveness of a new system to reduce lead migration during spinal cord stimulation therapy trials.
STIMFIX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days or depending on the post trial period (per standard of care)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days or depending on the post trial period (per standard of care)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To measure the Average Lead Migration in all 50 patients during the post trail follow up period
STIMFIX Trial Design
1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment1 Intervention
A total of 50 subjects who are undergoing dorsal column stimulator trial will be studied and placed on the SECURE study where their trial leads will be anchored using the StimfixTM system. The trial duration will be for seven days as per standard of care.
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Who is running the clinical trial?
STIMFIXLead Sponsor
Phillip Lim, DO, MPHPrincipal InvestigatorNuvation Pain Group
Dipan Patel, MDPrincipal InvestigatorGarden State Pain Control Center
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