Clinical Evaluation of Linear Z for Body Contouring
Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks
This clinical study will evaluate the safety and effectiveness of LinearZ, a non-invasive focused ultrasound device, for body contouring of the lower abdomen and flanks.
Approximately 30 adults with localized fat in the abdomen and flanks will participate in the study. Each participant will receive one treatment with LinearZ to the lower abdomen and flanks and will be followed for approximately 90 days.
The main purpose of the study is to determine whether treatment with LinearZ reduces the circumference of the treated area 90 days after treatment. The study will also evaluate changes in body circumference at Day 30, changes in body contour and appearance, participant satisfaction, body weight, body mass index (BMI), and body composition. Standardized photographs and three-dimensional images will also be used to assess changes in the treated areas.
The safety and tolerability of the treatment will be evaluated throughout the study by monitoring adverse events and treatment-related pain or discomfort.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the safety and effectiveness of LinearZ for non-invasive body contouring of the lower abdomen and flanks.
Approximately 30 eligible adult participants with localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks will be enrolled. All eligible participants will receive a single treatment with LinearZ to the lower abdomen and bilateral flanks. There is no randomization or comparator group in this study.
LinearZ is a focused ultrasound device designed to deliver ultrasound energy at specific depths within subcutaneous tissue for non-invasive body contouring. Treatment will be performed according to predefined study procedures and sponsor-approved treatment instructions. Treatment parameters, including the treatment area, cartridge type, treatment depth, energy level, and number of treatment lines or shots, will be documented.
Participants will undergo screening and baseline assessments before treatment and will return for follow-up assessments approximately 30 and 90 days after treatment.
The primary effectiveness assessment is the change from baseline in the circumference of the treated area at Day 90. Circumference measurements will be performed using standardized procedures at predefined anatomical landmarks.
Additional effectiveness assessments include change in circumference at Day 30, aesthetic improvement, participant satisfaction, changes in body weight and body mass index (BMI), and changes in body composition. Standardized clinical photography and three-dimensional imaging will also be used to document and evaluate changes in body contour. Independent blinded evaluators will review standardized images to help minimize assessment bias.
Safety and tolerability will be evaluated throughout the study by monitoring treatment-emergent adverse events, device-related adverse events, serious adverse events, and treatment-related pain or discomfort. Immediate post-treatment skin reactions and other local responses will also be assessed.
Each participant will participate in the study for approximately 90 days from the day of treatment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Narendra Kumar, Dr., PhD
- Número de teléfono: +65 9238 3614
- Correo electrónico: narendrakumar@jeisys.com
Ubicaciones de estudio
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Monterrey
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Nuevo León, Monterrey, México, 64060
- Reclutamiento
- Especialistas de la Piel y Cirugía, S.C.
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Contacto:
- Hector Leal Leal, Dr.
- Número de teléfono: +528119655342
- Correo electrónico: hleal@iderma.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 to 65 years.
- Participants of either sex.
- Body mass index (BMI) greater than 20 kg/m².
- Presence of localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks considered adequate for non-invasive body contouring by the investigator.
- Minimum subcutaneous fat thickness of 30 mm, assessed clinically or by caliper/ultrasound.
- Stable body weight (±3 kg) for the past 3 months.
- Willingness to maintain stable diet and exercise habits during study participation.
- Ability to comply with study requirements.
- Provision of written informed consent.
- Compliance with other clinical criteria defined for the study.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Women planning pregnancy during study participation.
- Previous body contouring procedures in the treatment area within the past 6 months.
- Moderate to severe skin laxity in the treatment area that, in the investigator's judgment, is likely to interfere with assessment of body-contouring results.
- Active dermatologic conditions or infections.
- Implanted electronic devices, such as a pacemaker or implanted defibrillator.
- Coagulation disorders.
- Use of anticoagulant therapy.
- Severe uncontrolled systemic disease.
- Participation in another clinical investigation within the previous 30 days.
- Any contraindication listed in the device manual.
- Hernia in the treatment area.
- Metal implants in the treatment area.
- Significant open scars, tattoos, or wounds in the treatment area.
- Altered sensation or neuropathy.
- Active malignancy.
- History of keloid formation or poor wound healing.
- Use of weight-loss medications or GLP-1 agonists within the previous 3 months.
- Previous liposuction or surgery in the treatment area within the previous 12 months.
- Psychiatric conditions that affect the ability to provide informed consent or that affect body-image perception.
- Women of childbearing potential who are unwilling to use medically acceptable contraception during study participation.
- Any participant who, in the investigator's opinion, is not suitable for participation or is unlikely to comply with study procedures or complete the study.
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 |
|---|---|
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Experimental: A single-arm study where subjects will receive HIFU for non invasive body contouring
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks.
Treatment will be performed according to the predefined study treatment parameters.
Participants will be followed for approximately 90 days after treatment to evaluate the safety and effectiveness of the treatment.
|
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks.
The device delivers focused ultrasound energy at specific depths within the subcutaneous tissue.
Treatment will be performed according to the sponsor-approved treatment manual, site-specific operating procedures, and study procedures.
All participants will receive treatment to both the lower abdomen and flanks during the treatment session and will be followed for approximately 90 days after treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Circumference of the Target Area at Day 90
Periodo de tiempo: Baseline to day 90
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The change in circumference of the treated target area from baseline to Day 90 will be assessed using standardized circumference measurements.
The target area includes the lower abdomen and bilateral flanks.
Circumference will be measured at a predefined and documented anatomical level using a standardized procedure, and the average of three consecutive measurements will be used for analysis.
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Baseline to day 90
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Circumference of the Target Area at Day 30
Periodo de tiempo: Baseline to Day 30
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Change in circumference of the treated target area from baseline to Day 30 will be assessed using standardized circumference measurements at predefined anatomical points encompassing the lower abdomen and bilateral flanks.
The average of three consecutive measurements will be used for analysis.
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Baseline to Day 30
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Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90
Periodo de tiempo: Baseline to Day 90
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Percentage of participants who achieve a reduction of at least 5 cm in circumference of the treated target area compared with baseline.
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Baseline to Day 90
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Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90
Periodo de tiempo: Baseline to day 90
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Percentage of participants who achieve a reduction of at least 10 cm in circumference of the treated target area compared with baseline.
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Baseline to day 90
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Global Aesthetic Improvement Scale (GAIS) Score
Periodo de tiempo: Day 30 and Day 90
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Aesthetic improvement of the treated area will be assessed using the Global Aesthetic Improvement Scale (GAIS) at follow-up visits.
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Day 30 and Day 90
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Blinded Independent Photographic Evaluation of Aesthetic Improvement
Periodo de tiempo: Baseline, Day 30 and Day 90
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Independent blinded evaluators will assess aesthetic improvement using standardized photographs obtained at baseline and follow-up visits.
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Baseline, Day 30 and Day 90
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Participant Satisfaction With Treatment Outcome
Periodo de tiempo: Day 30 and Day 90
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Participant satisfaction with the treatment outcome will be assessed using the study-specified satisfaction questionnaire.
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Day 30 and Day 90
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Change From Baseline in Body Weight
Periodo de tiempo: Baseline to Day 30 and Day 90
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Change in participant body weight from baseline will be assessed at follow-up visits.
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Baseline to Day 30 and Day 90
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Change From Baseline in Body Mass Index (BMI)
Periodo de tiempo: Baseline to Day 30 and Day 90
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Change in BMI from baseline will be assessed at follow-up visits.
BMI is expressed in kg/m².
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Baseline to Day 30 and Day 90
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Change From Baseline in Fat Mass and Fat-Free Mass
Periodo de tiempo: Baseline to Day 30 and Day 90
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Change in fat mass and fat-free mass from baseline will be assessed using the InBody body composition measurement system.
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Baseline to Day 30 and Day 90
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Procedural Pain and Discomfort Score Using an 11-Point Numeric Rating Scale
Periodo de tiempo: Immediately after each treatment.
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Procedural pain associated with radiofrequency treatment will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater procedural pain.
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Immediately after each treatment.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events
Periodo de tiempo: From treatment through Day 90
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Treatment-emergent adverse events will be monitored from the treatment procedure through the final follow-up visit.
Adverse events will be assessed for severity and relationship to the study device/procedure in accordance with the study protocol.
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From treatment through Day 90
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Otros números de identificación del estudio
- LIN-BD-01-2026
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.
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