BACK4 Safety Evaluation

SWIMS America Corp.

Status: Completed

Conditions: Safety and Tolerability in Healthy Subjects

Treatments: Device: Treatment with BACK4 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07153900

SF-B4-001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 22 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 22-55 years old
• Able to provide written informed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Hands-on

Active Comparator group

Description:

Treatment delivered by therapist utilizing multipolar electrode

Treatment:

Device: Treatment with BACK4 System

Hands-free

Active Comparator group

Description:

Treatment delivered utilizing fixed pads

Treatment:

Device: Treatment with BACK4 System