Safety and Tolerability in Healthy SubjectsNCT07153900
BACK4 Safety Evaluation
A study testing Treatment with BACK4 System in people with Safety and Tolerability in Healthy Subjects, run by SWIMS America Corp. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Subjects
- What is being tested?
- Treatment with BACK4 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 22-55 years old
- Able to provide written informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety Evaluation of BACK4 Device
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.
- Being tested
- Treatment with BACK4 System
- Keywords
- muscle stimulation, topical heating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BACK4 SystemDevice
Use of combined RF and EMS therapy with BACK4 Device
| Study group | Role | What they receive |
|---|---|---|
| Hands-on | Active comparator | Treatment delivered by therapist utilizing multipolar electrode Receives: Device: Treatment with BACK4 System |
| Hands-free | Active comparator | Treatment delivered utilizing fixed pads Receives: Device: Treatment with BACK4 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a reported Adverse Event
Characterize the number of adverse events for the combined use of RF and EMS with the BACK4 device across the device's intended configurations
Measured: 7 days
Secondary outcomes (2)
Number of participants with a device-related adverse event
Characterize the number of device-related adverse events for the combined use of RF and EMS in terms of with the BACK4 device across the device's intended configurations
Measured: 7 days
Number of patients reporting therapy tolerability
Therapy tolerability assessment will be ascertained by the subject using a 5-point scale (1=very uncomfortable, 2=somewhat uncomfortable, 3=neutral, 4=somewhat comfortable, 5=very comfortable)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWIMS America Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153900
- Sponsor's protocol ID
- SF-B4-001
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of BACK4 Device
- ClinicalTrials.gov ID
- NCT07153900
- Acronym / sponsor ID
- SF-B4-001
- Keywords
- muscle stimulation, topical heating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SWIMS America Corp.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands-on | Active comparator | Device: Treatment with BACK4 SystemTreatment delivered by therapist utilizing multipolar electrode |
| Hands-free | Active comparator | Device: Treatment with BACK4 SystemTreatment delivered utilizing fixed pads |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults 22-55 years old
- Able to provide written informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BACK4 SystemUse of combined RF and EMS therapy with BACK4 Device | Device | Hands-free, Hands-on |
Primary outcome
Number of participants with a reported Adverse Event
Time frame: 7 days
Characterize the number of adverse events for the combined use of RF and EMS with the BACK4 device across the device's intended configurations
2 secondary outcomes
Number of participants with a device-related adverse event
Time frame: 7 days
Number of patients reporting therapy tolerability
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BACK4 System in people with Safety and Tolerability in Healthy Subjects, run by SWIMS America Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a reported Adverse Event (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.