Clinical Trial

BACK4 Safety Evaluation

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-08-26; most recent amendment 2025-12-30.
Status change: Active, Not Recruiting → Completed 2025-12-30
Status change: Recruiting → Active, Not Recruiting 2025-10-21
Status change: Not Yet Recruiting → Recruiting 2025-09-22
Trial Details
NCT Number NCT07153900
Lead Sponsor SWIMS America Corp.
Conditions Safety and Tolerability in Healthy Subjects
Enrollment 24 participants
Start Date 2025-10-01
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-01-02