Combination Treatment With BTL-899 and HPM-6000UF Devices II
Completed · Not applicable
Conditions studied: Muscle Weakness
In brief
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 female patients after childbirth.
Key facts
- Study ID
- NCT05713864
- Run by
- BTL Industries Ltd.
- People needed
- 33
- Starts
- 2022-03-08
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2023-04-13
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy female subjects aged 22 years or older who have given birth to a baby 6 to 60 months prior to their enrolment in the study seeking treatment for strengthening their pelvic floor and abdominal muscles
- Having a body mass index (BMI) less than 35 kg/m2
- 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.
You may not qualify if…
- Ongoing Pregnancy, nursing or IVF procedure
- 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
- Scars in the treatment area
- Metal containing Intrauterine Device (IUD)
Where it is running
- Contour Medical — Gilbert, Arizona, United States
- Julene B. Samuels — River Bluff, Kentucky, United States
- Southern Urogynecology — West Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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