Pure Impact for Muscle Tone

Overseen By Ruthie Amir, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Sofwave Medical LTD

Must not be taking: Immunosuppressants

Disqualifiers: Diabetes, Hypertension, Cardiac disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of the Pure Impact Treatment, which uses electrical impulses to boost muscle strength and tone. Participants will have electrodes placed on their skin near targeted muscles, such as the abdomen, quadriceps, hamstrings, or glutes. This treatment suits individuals committed to maintaining their weight and enhancing muscle strength without significant changes to diet or exercise routines. The study invites those without major health issues or specific conditions that might interfere with the treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially enhance muscle strength in a new way.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using immunosuppressive medications or have certain medical conditions, you may not be eligible to participate.

What prior data suggests that the Pure Impact Treatment is safe for muscle stimulation?

Research has shown that the Pure Impact Treatment, which uses electrical muscle stimulation (EMS) to tone muscles, has been safe in past studies. This treatment sends small electrical signals to muscles, causing them to contract and strengthen over time.

The FDA has cleared the Pure Impact device, indicating it has met certain safety standards for muscle strengthening. While FDA clearance does not guarantee it is completely risk-free, it does confirm adherence to these standards.

Few reports of serious side effects have emerged with this treatment. Most individuals tolerate it well, though some may experience mild discomfort, such as tingling or muscle soreness, similar to post-exercise sensations. Overall, current research suggests that the Pure Impact Treatment is a safe option for muscle toning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pure Impact Treatment for muscle tone because it uses electrical muscle stimulation (EMS), a unique approach that generates electrical impulses delivered through electrodes on the skin. This method directly targets muscles, potentially enhancing muscle strength more effectively than traditional methods like resistance training or physical therapy alone. Unlike standard treatments, which often require extensive time and physical effort, Pure Impact offers a non-invasive and potentially quicker way to improve muscle tone.

What evidence suggests that the Pure Impact Treatment is effective for improving muscle tone?

Research has shown that Pure Impact Treatment, which uses electrical muscle stimulation (EMS), can help strengthen and tone muscles. In this trial, participants in the experimental arm will receive the Pure Impact Treatment. Studies have found that this treatment leads to greater muscle strength improvements compared to those who do not receive it. The treatment sends small electrical signals to muscles, causing them to contract and build strength over time. Increased muscle tone, firmness, and strength often become noticeable in the weeks following treatment. Regular sessions and a healthy lifestyle can help maintain these improvements. ^{1 2 6 7 8}

Who Is on the Research Team?

Ahlam Safadi, BSC

Principal Investigator

Sofwave Medical LTD

Are You a Good Fit for This Trial?

This trial is for men and women aged 25 to 60 who are not pregnant or breastfeeding. Participants must want treatments for their abdomen, quadriceps, hamstrings, or glutes to improve muscle strength and tone. They should be willing to keep their weight stable, follow the study's schedule, and consent to having photos taken of treated areas.

Inclusion Criteria

I can attend all appointments and follow study rules.

I agree to keep my weight stable and not change my diet or exercise routine significantly during the study.

I am willing to let doctors take photos of my treatment areas for research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants in the test group receive 6 Pure Impact treatments on the abdomen, quadriceps, and/or hamstring and glutes once a week

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pure Impact Treatment

Trial Overview The 'Pure Impact' treatment is being tested in this clinical trial. It's an open-label study where everyone knows what treatment they're getting—there's no placebo group. The goal is to see if Pure Impact can strengthen and tone muscles in the abdomen and legs.

How Is the Trial Designed?

Group I: Muscle strength Experimental Treatment 1 Intervention

Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.

Group II: Control Active Control 1 Intervention

Control group will be followed but will not be treated.

Who Is Running the Clinical Trial?

Sofwave Medical LTD

Lead Sponsor

Trials

11

Recruited

640+

Citations

1. sofwave.com sofwave.com/providers/technologies/pure-impact

Pure Impact Pure Impact is a non-invasive muscle toning treatment using PlyoPulse™ technology, that can strengthen, tone, and firm the abdomen, buttocks, thighs, and arms ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07094971

Pure Impact Treatment to Strengthen and Tone Abdomen ... Higher improvement rate of the muscles strength tests at the test group compared to the control group using series of exercises tests including questionnaire, ...

3. msn.com msn.com/en-us/health/other/sofwave-medical-s-new-study-on-pure-impact-device-a-potential-game-changer-in-muscle-enhancement/ar-AA1Pixx4

Sofwave Medical's New Study on Pure Impact Device ' The study aims to evaluate the safety and effectiveness of the Pure Impact device, which uses electrical muscle stimulation (EMS) to enhance muscle tone and ...

4. withpower.com withpower.com/trial/phase-strength-muscle-6-2025-22b90

Pure Impact for Muscle Tone It's an open-label study where everyone knows what treatment they're getting—there's no placebo group. The goal is to see if Pure Impact can strengthen and tone ...

5. lavieplasticsurgery.com lavieplasticsurgery.com/non-surgical/anti-aging/pure-impact-by-sofwave/

Pure Impact™ by Sofwave | Non-Invasive Muscle Toning at ... Results—tone, firmness, strength—develop over subsequent weeks. Maintenance every 2–3 months, coupled with a healthy lifestyle, helps sustain outcomes. Why ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K241685.pdf

August 7, 2024 Sofwave Medical Ltd. Ruthie Amir Chief ... The Pure Impact module is indicated to be used for: • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development ...

7. finance.yahoo.com finance.yahoo.com/news/sofwave-receives-fda-pre-market-123000318.html

Sofwave Receives FDA, Pre-market Clearance for Pure ... Sofwave Receives FDA, Pre-market Clearance for Pure Impact VIPTM Standalone EMS Device For Comprehensive Multi-Body Area Muscle Strengthening ...

8. tipranks.com tipranks.com/news/company-announcements/sofwave-medicals-new-study-on-pure-impact-device-a-potential-game-changer-in-muscle-enhancement

Sofwave Medical's New Study on Pure Impact Device ' The study aims to evaluate the safety and effectiveness of the Pure Impact device, which uses electrical muscle stimulation (EMS) to enhance ...