Sofwave + Pure Impact for Sagging Skin

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sofwave Medical LTD

No Placebo Group

Trial Summary

What is the purpose of this trial?Open-label, non-randomized, prospective, multi-center, self-controlled clinical study.

Eligibility Criteria

This trial is for men and women aged 25-70 with visible sagging skin on the upper arms who want to improve it. Participants must be able to follow the study plan, not have other arm treatments for 3 months after joining, and keep their weight stable. They can't join if they're pregnant or breastfeeding, allergic to certain anesthetics or hydrogel, very overweight, heavy smokers, or have a history of certain diseases.

Inclusion Criteria

I am between 25 and 70 years old.

Exclusion Criteria

I have had cancer or still have it within the last 5 years.

I have major issues with lymphatic drainage.

I have been a heavy smoker or was one in the past 10 years.

I have muscle loss, need muscle rehab, or have ongoing pain where I was treated.

I have a hormone imbalance related to my thyroid, pituitary, or androgen levels.

I have a tattoo or had one removed near the treatment area.

I have significant scarring or keloids where I would receive treatment.

I have a bleeding disorder or take medication that could increase bruising.

I do not have skin issues like infections or wounds in the area to be treated.

I do not have major health issues like heart disease, uncontrolled high blood pressure, or liver/kidney disease.

I understand the study details and can give informed consent.

I have a history of immune system disorders or am currently on immunosuppressive medication.

Participant Groups

The trial tests Sofwave and Pure Impact treatments combined to see how well they strengthen muscles and tighten loose skin on the upper arms. It's an open-label study where everyone knows what treatment they get; it's also non-randomized so there’s no chance involved in who gets treated.

1Treatment groups

Experimental Treatment

Group I: Lax Tissue and MusclesExperimental Treatment1 Intervention