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BACK4 Safety Evaluation

NCT07153900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-02

No results posted yet for this study

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.

Conditions

  • Safety and Tolerability in Healthy Subjects

Interventions

DEVICE

Treatment with BACK4 System

Use of combined RF and EMS therapy with BACK4 Device

Sponsors & Collaborators

  • SWIMS America Corp.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-11-30
Completion
2025-12-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153900 on ClinicalTrials.gov