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Completed
NCT05713864
Combination Treatment With BTL-899 and HPM-6000UF Devices II
Conditions: Muscle Weakness
Sex: Female
Ages: 22 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 33
Sponsor: BTL Industries Ltd.
Location: United States
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 female patients after childbirth.
Eligibility Criteria
Inclusion Criteria: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 musclesHaving a body mass index (BMI) less than 35 kg/m2Subjects 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:Ongoing Pregnancy, nursing or IVF procedureElectronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)Metal implants in the treated areaDrug pumpsMalignant tumorPulmonary insufficiencyInjured or otherwise impaired muscles in the treated areaCardiovascular diseasesDisturbance of temperature or pain perceptionHemorrhagic conditionsSeptic conditions and empyemaAcute inflammations in the treated areaSystemic or local infection such as osteomyelitis and tuberculosisContagious skin diseaseElevated body temperaturePoor healing and unhealed wounds in the treatment areaFollowing recent surgical procedures when muscle contraction may disrupt the healing processGraves' diseaseScars in the treatment areaMetal containing Intrauterine Device (IUD)
Source: ClinicalTrials.gov (NCT05713864). StuddyBuddy aggregates publicly available trial information.
