RECRUITING

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

Conditions

Muscle Strengh Muscle Tone Abdomen Hamstring Quadriceps Glutes skin laxity muscle strength muscle firm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-11

Study Completion:2026-07-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07094971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female subjects ≥ 25 years of age and ≤ 60 years of age. 2. 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. 3. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles. 4. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study. 5. Able and willing to comply with all visits, treatments and evaluations schedules and requirements. 6. Willing to have research photos taken of treatment areas. 7. Able to understand and provide written Informed Consent.	1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. 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. 3. Active malignancy or history of malignancy in the past 5 years. 4. 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). 5. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. 6. BMI \< 18 or \>35kg/m2 7. Non-stable weight nominally ±5% in the past month. 8. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body. 9. 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. 10. History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years. 11. History of prior surgery in the treated areas at the last 2 years. 12. Excessive subcutaneous fat on the treated areas. 13. Abdominal or inguinal hernia 14. Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash. 15. Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel). 16. History of chronic drug or alcohol abuse. 17. Muscle atrophy. 18. Need for muscle rehabilitation. 19. Persistent pain at the treated area. 20. Inability to understand the protocol or to give informed consent. 21. Unable or unwilling to comply with the study requirements and procedures. 22. Currently enrolled in a clinical study of any other unapproved investigational drug or device. 23. Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject. 24. Presence of any active systemic or local infections. 25. Significant scarring in the area to receive study treatment. 26. Suspected or diagnosed heart problems. 27. Areas of the skin that lack normal sensation.

Inclusion Criteria

Exclusion Criteria

1. Male or female subjects ≥ 25 years of age and ≤ 60 years of age.
2. 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.
3. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles.
4. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exercise changes during the study.
5. Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
6. Willing to have research photos taken of treatment areas.
7. Able to understand and provide written Informed Consent.

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. 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.
3. Active malignancy or history of malignancy in the past 5 years.
4. 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).
5. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
6. BMI \< 18 or \>35kg/m2
7. Non-stable weight nominally ±5% in the past month.
8. Active implanted device such as a pacemaker, defibrillator, drug delivery system or any other metallic or electric implant anywhere in the body.
9. 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.
10. History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) at the last 2 years.
11. History of prior surgery in the treated areas at the last 2 years.
12. Excessive subcutaneous fat on the treated areas.
13. Abdominal or inguinal hernia
14. Any active condition in the treatment area, such as open wounds, sores, psoriasis, eczema, and rash.
15. Any sensitivity for hydrogel (Pure Impact electrodes pads are made of hydrogel).
16. History of chronic drug or alcohol abuse.
17. Muscle atrophy.
18. Need for muscle rehabilitation.
19. Persistent pain at the treated area.
20. Inability to understand the protocol or to give informed consent.
21. Unable or unwilling to comply with the study requirements and procedures.
22. Currently enrolled in a clinical study of any other unapproved investigational drug or device.
23. Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
24. Presence of any active systemic or local infections.
25. Significant scarring in the area to receive study treatment.
26. Suspected or diagnosed heart problems.
27. Areas of the skin that lack normal sensation.

Contacts and Locations

Study Contact

Shlomit Mann, MSc

CONTACT

047800268

shlomit@sofwave.com

Ruthie Amir, MD

CONTACT

043003164

ruthie@sofwave.com

Principal Investigator

Ahlam Safadi, BSC

STUDY_DIRECTOR

Sofwave Medical LTD

Study Locations (Sites)

Movassaghi Plastic Surgery & Ziba Medical Spa

Eugene, Oregon, 97401

United States

Collaborators and Investigators

Sponsor: Sofwave Medical LTD

Ahlam Safadi, BSC, STUDY_DIRECTOR, Sofwave Medical LTD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11

Study Completion Date2026-07-10

Study Record Updates

Study Start Date2025-07-11

Study Completion Date2026-07-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Muscle Strengh
Muscle Tone