NCT07094971

Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles

Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Sofwave Medical LTD · Industry
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Open-label, non-randomized, prospective, single-center, self-controlled clinical study.

Detailed description

Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated. The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group). Subjects of the test group will receive 6 Pure Impact treatments on the abdomen and quadriceps, and/or hamstring and glutes once a week. First treatment may be administered after the enrolment and screening at the first visit, or it may occur later following the enrolment and screening activities based on site scheduling availabilities. Overall, all treatments are done within 6 weeks. All subjects will return to the clinic for follow-up visit at 4±1 weeks post last treatment.

Conditions

• Muscle Tone
• Muscle Strength

Interventions

Type	Name	Description
DEVICE	Pure Impact	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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2026-07-10
• Completion: 2026-07-10
• First posted: 2025-07-31
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study