CoolSculpting of the Flank With Alternate Treatment Parameters
9 de febrero de 2021 actualizado por: Zeltiq Aesthetics
Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
Tipo de estudio
Intervencionista
Inscripción (Actual)
45
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6JIZ6
- Arbutus Laser Centre
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-
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California
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Sacramento, California, Estados Unidos, 95816
- Laser & Skin Surgery Center of Northern California
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Dallas Plastic Surgery Institute
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria
- Male or female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Exclusion Criteria
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
- Subject is lactating or has been lactating in the past 6 months.
- Subject has a history of hernia in the areas to be treated.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- 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: CoolSculpting of the Flank With Alternate Treatment Parameters
Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
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El enfriamiento no invasivo se aplica al área de tratamiento con una velocidad y duración de enfriamiento definidas.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Number of Device and/or Procedure-Related Adverse Events
Periodo de tiempo: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
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The number of device- or procedure-related adverse events will be tabulated.
Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit.
The investigator determines if there is a relationship between the event and the study device or procedure.
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Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
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Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Periodo de tiempo: Pre-treatment and 16 weeks post-treatment
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Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated contralateral flank control area.
The Sponsor's standardized techniques for obtaining ultrasound imaging will be used.
Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations.
Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank.
Results indicate the fat layer reduction in millimeters.
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Pre-treatment and 16 weeks post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Pre-treatment Images Correctly Identified.
Periodo de tiempo: 16 weeks post-treatment
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Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images.
Images show both treated and untreated flanks.
Reviewers will be practicing dermatologists or plastic surgeons.
Reviewers will be blinded to post-treatment vs. baseline untreated area.
The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images.
Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form.
Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure.
The expected success rate is 80% correct identification.
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16 weeks post-treatment
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Subject Satisfaction
Periodo de tiempo: 16 weeks post-treatment
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Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.
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16 weeks post-treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de febrero de 2014
Finalización primaria (Actual)
27 de junio de 2014
Finalización del estudio (Actual)
27 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2014
Publicado por primera vez (Estimar)
7 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de febrero de 2021
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZA13-005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
Sí
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. .