- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04596228
Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs
Effect of BTL-899 Device for Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs
Descripción general del estudio
Descripción detallada
This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of inner thighs. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit, MRI imaging will be performed; the subject's weight and thigh circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicator of BTL-899 will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Each therapy session will last 30 minutes.
At the last therapy visit, the subject's weight and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive a Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE), including the subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo a MRI imaging. Also, the subject's satisfaction will be noted, and weight with thigh circumference will be recorded. Photographs of the treated area will be taken. In addition, subjects will receive a Lifestyle Change Questionnaire to fill in.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80525
- Plastic Surgical Associates
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pinchable fat layer at the thigh region
- Age > 21 years
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
Exclusion Criteria:
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- Intrauterine device (IUD)
- Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
- Basedow's disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experimental
Subjects will be required to complete four (4) treatment visits and two follow-up visits.
All of the study subjects will receive the treatment with the subject device
|
Tratamiento con intensidades de un campo magnético y energía de radiofrecuencia justo por debajo del umbral de tolerancia del paciente.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The evaluation of structural changes of subcutaneous tissues of the inner thighs
Periodo de tiempo: 4 months
|
The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues.
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4 months
|
The evaluation of structural changes of subcutaneous tissues of the inner thighs
Periodo de tiempo: 4 months
|
The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through evaluation of tissue composition and morphology.
|
4 months
|
The evaluation of change in adipose layer thickness
Periodo de tiempo: 4 months
|
The evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on thigh circumference measurements.
|
4 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluación de la Seguridad de la Terapia Medida a través del Cuestionario de Comodidad de la Terapia
Periodo de tiempo: 4 meses
|
El resultado se medirá además a través de la ocurrencia de eventos adversos o la ausencia de los mismos.
En la escala analógica numérica (0-10), donde 0 representa "sin dolor" y 10 representa "el peor dolor posible", seleccione el nivel de dolor experimentado durante el tratamiento.
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4 meses
|
Patient's satisfaction with study treatment measured via questionnaires
Periodo de tiempo: 4 months
|
To determine the patient's satisfaction with study treatment for non-invasive lipolysis and improvement of muscle tone in inner thighs.
The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome.
Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.
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4 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BTL-899_200
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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