Status:
COMPLETED
BACK4 Safety Evaluation
Lead Sponsor:
SWIMS America Corp.
Conditions:
Safety and Tolerability in Healthy Subjects
Eligibility:
All Genders
22-55 years
Phase:
NA
Brief Summary
To characterize the safety of combined RF and EMS therapies with the BACK4 device in healthy volunteers. Subjects will receive 3 treatments of increasing intensity over a one week period.
Eligibility Criteria
Inclusion
- Adults 22-55 years old
- Able to provide written informed consent
Exclusion
- Injury within the past 30 days
- Cancer or cancerous lesions in the treatment area
- Skin disorders (e.g., eczema, shingles), skin burns, or open wounds
- Coagulation disorders, phlebitis, or thrombophlebitis
- Insensitivity to heat
- Local insensitivity to pain and/or touch
- Fever, bacterial infection, infectious disease, or tuberculosis
- Severe hypertension or hypotension
- Electrical implants (e.g., pacemaker, insulin pump, neurostimulator)
- History of seizures or recent surgery
- Known hypersensitivity to device materials
- Pregnant or breastfeeding women
- Participation in another clinical trial within 30 days
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07153900
Start Date
October 1 2025
End Date
December 25 2025
Last Update
January 2 2026
Active Locations (1)
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1
RORE Method
Birmingham, Michigan, United States, 48009