Muscle ToneNCT07094971
Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
A study testing Pure Impact in people with Muscle Tone and Muscle Strength, run by Sofwave Medical LTD at 1 site in United States.
Trial summary
Open-label, non-randomized, prospective, single-center, self-controlled clinical study. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone, Muscle Strength
- What is being tested?
- Pure Impact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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).
- History of chronic drug or alcohol abuse.
- Muscle atrophy.
- Need for muscle rehabilitation.
- Persistent pain at the treated area.
- Inability to understand the protocol or to give informed consent.
- Unable or unwilling to comply with the study requirements and procedures.
- Currently enrolled in a clinical study of any other unapproved investigational drug or device.
- 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.
- Presence of any active systemic or local infections.
- Significant scarring in the area to receive study treatment.
- Suspected or diagnosed heart problems.
- Areas of the skin that lack normal sensation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Movassaghi Plastic Surgery & Ziba Medical Spa
Eugene, Oregon, 97401
janna Check, 541-686-8700, janna@drmovassaghi.com
niloo Marashi, 541-686-8700, niloo@drmovassaghi.com
About this study
Official title: Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Read the detailed description
Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated.
The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group).
Subjects of the test group will receive 6 Pure Impact treatments on the abdomen and quadriceps, and/or hamstring and glutes once a week.
First treatment may be administered after the enrolment and screening at the first visit, or it may occur later following the enrolment and screening activities based on site scheduling availabilities.
Overall, all treatments are done within 6 weeks.
All subjects will return to the clinic for follow-up visit at 4±1 weeks post last treatment.
- Conditions
- Muscle Tone, Muscle Strength
- Being tested
- Pure Impact
- Keywords
- Abdomen, Hamstring, Quadriceps, Glutes, skin laxity, muscle tone, muscle strength, muscle firm
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure ImpactDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pure Impact |
| Control | No intervention | Control group will be followed but will not be treated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month post last treatment follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start11 Jul 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle ToneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofwave Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahlam Safadi, BSC, Study director, Sofwave Medical LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094971
- Sponsor's protocol ID
- Sofwave27
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pure Impact to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
- ClinicalTrials.gov ID
- NCT07094971
- Acronym / sponsor ID
- Sofwave27
- Conditions
- Muscle Tone, Muscle Strength
- Keywords
- Abdomen, Hamstring, Quadriceps, Glutes, skin laxity, muscle tone, muscle strength, muscle firm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sofwave Medical LTDIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Detailed description
Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated.
The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group).
Subjects of the test group will receive 6 Pure Impact treatments on the abdomen and quadriceps, and/or hamstring and glutes once a week.
First treatment may be administered after the enrolment and screening at the first visit, or it may occur later following the enrolment and screening activities based on site scheduling availabilities.
Overall, all treatments are done within 6 weeks.
All subjects will return to the clinic for follow-up visit at 4±1 weeks post last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle strength | Experimental | Device: Pure ImpactPure 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. |
| Control | No intervention | –Control group will be followed but will not be treated. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure ImpactPure 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 | Muscle strength |
Primary outcome
Improvement rate of the muscles strength
Time frame: 1 Month post last treatment follow up visit
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahlam Safadi, BSC study director
Sofwave Medical LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure Impact in people with Muscle Tone and Muscle Strength, run by Sofwave Medical LTD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shlomit Mann, MSc (047800268, shlomit@sofwave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of the muscles strength (time frame: 1 Month post last treatment follow up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.