Actively Recruiting

Phase Not Applicable
Age: 25Years - 60Years
All Genders
Healthy Volunteers
NCT07094971

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

Led by Sofwave Medical LTD · Updated on 2025-08-03

44

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects 25 to 60 years of age
  • Not pregnant or lactating and must be post-menopausal, surgically sterilized, or using medically acceptable birth control for at least 3 months prior
  • Desire to receive treatment on abdomen and quadriceps and/or hamstring and glutes for muscle strength and tone
  • Agree to maintain weight within 5% of total body weight and avoid major dietary or exercise changes during the study
  • Able and willing to attend all visits, treatments, and evaluations as scheduled
  • Willing to have research photos taken of treatment areas
  • Able to understand and provide written informed consent
Not Eligible

You will not qualify if you...

  • Pregnant, planning pregnancy, given birth less than 3 months ago, or breastfeeding
  • Medical disorders affecting wound healing or immune response, including arterial circulation disorders and inflammatory diseases
  • Active cancer or history of cancer in the past 5 years
  • Significant illnesses such as cardiac disorders, sensory disturbances, diabetes, epilepsy, lupus, porphyria, neurological disorders, uncontrolled hypertension, liver or kidney disease
  • History of immunosuppression or immune deficiency, including HIV/AIDS, or use of immunosuppressive medications
  • Body mass index less than 18 or greater than 35 kg/m2
  • Unstable weight (more than ±5%) in the past month
  • Presence of active implanted devices like pacemakers or defibrillators
  • Permanent implants in treated areas including metal plates, screws, piercings, silicone implants, or injected substances unless deeply placed
  • Fat reduction procedures or surgery in treated areas within the last 2 years
  • Excessive subcutaneous fat or hernia in treated areas
  • Active skin conditions or wounds in the treatment areas
  • Sensitivity to hydrogel used in electrode pads
  • History of chronic drug or alcohol abuse
  • Muscle atrophy or need for muscle rehabilitation
  • Persistent pain in treated areas
  • Inability to understand protocol or provide informed consent
  • Unwillingness or inability to comply with study procedures
  • Participation in other investigational drug or device studies
  • Any condition that may affect study response, data integrity, or participant safety as judged by the investigator
  • Active systemic or local infections
  • Significant scarring in treatment areas
  • Suspected or diagnosed heart problems
  • Areas of skin lacking normal sensation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Movassaghi Plastic Surgery & Ziba Medical Spa

Eugene, Oregon, United States, 97401

Actively Recruiting

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Research Team

S

Shlomit Mann, MSc

CONTACT

R

Ruthie Amir, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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