RecruitingNot Applicable

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

United States44 participantsStarted 2025-07-11

Plain-language summary

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

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
. Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence.
. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
. Willing to have research photos taken of treatment areas.
. Able to understand and provide written Informed Consent.

Exclusion criteria

. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
. Medical disorder that would hinder the wound healing or immune response (such as blood disorder) including but not limited to arterial circulation disorders in lower limbs, inflammatory disease, etc.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement rate of the muscles strength

Timeframe: 1 Month post last treatment follow up visit

Trial details

NCT IDNCT07094971

SponsorSofwave Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-10

Contact for this trial

Shlomit Mann, MSc

047800268 shlomit@sofwave.com

View on ClinicalTrials.gov More Muscle Tone trials