Combination Treatment With BTL-899 and HPM-6000UF Devices (NCT05537181) | Clinical Trial Compass
UnknownNot Applicable
Combination Treatment With BTL-899 and HPM-6000UF Devices
United States39 participantsStarted 2022-02-04
Plain-language summary
This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male or female subjects aged 60 years or older (postmenopause when female),
* BMI ≤35kg/m2 seeking treatment for strengthening their pelvic floor or abdominal muscles
* Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.
* Subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation.
* Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken.
Exclusion Criteria:
* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants in the treated area
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles in the treated area
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations in the treated area
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Poor healing and unhealed wounds in the treatment area
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Graves' disease
What they're measuring
1
Assessment of core muscles strength measured by pressure biofeedback device
Timeframe: 5 months
2
Assessment of subject's quality of life based on Subject Satisfaction and Experience Questionnaire