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

NCT07094971 | Recruiting FDA Device

• 1 other identifier: Sofwave27
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Muscle Tone; Muscle Strength

Keywords

Abdomen; Hamstring; Quadriceps; Glutes; skin laxity; muscle tone; muscle strength; muscle firm

Outcome Measures

Primary Outcomes (1)

• Improvement rate of the muscles strength

  Higher improvement rate of the muscles strength tests at the test group compared to the control group using series of exercises tests including questionnaire, and a functional evaluation of the muscles of the abdomen, quadriceps, and glutes.

  1 Month post last treatment follow up visit

Study Arms (2)

Muscle strength

EXPERIMENTAL

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.

Device: Pure Impact

Control

NO INTERVENTION

Control group will be followed but will not be treated.

Interventions

Pure Impact DEVICE

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.

Muscle strength

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Active malignancy or history of malignancy in the past 5 years.
• Suffering from significant concurrent illness, such as cardiac disorders, sensory disturbances, diabetes (type I or II), epilepsy, lupus, porphyria, pertinent neurological disorders, uncontrolled hypertension, or liver or kidney disease (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• BMI \< 18 or \>35kg/m2
• Non-stable weight nominally ±5% in the past month.
• Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.
• Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years.
• History of prior surgery in the treated areas at the last 2 years.
• Excessive subcutaneous fat on the treated areas.
• Abdominal or inguinal hernia
• Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.
• Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).

Sponsors & Collaborators

• Sofwave Medical LTD: lead

Study Sites (1)

Movassaghi Plastic Surgery & Ziba Medical Spa

Eugene, Oregon, 97401, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Ahlam Safadi, BSC

  Sofwave Medical LTD

  STUDY DIRECTOR

Central Study Contacts

Shlomit Mann, MSc

CONTACT

047800268; shlomit@sofwave.com

Ruthie Amir, MD

CONTACT

043003164; ruthie@sofwave.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: July 31, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)