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New treatment option for Muscle Tone
Official title Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles
ClinicalTrials.gov ID: NCT07094971
What this study is testing
- What it's testing
- Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people ≥ 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...
- 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.
You likely can't join 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...
- 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...
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- BMI \ 35kg/m2
See the full eligibility criteria
- Male or female people ≥ 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...
- 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.
- 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...
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- BMI \ 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Eugene, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eugene, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.