CoolSculpting of the Flank With Alternate Treatment Parameters
9 de fevereiro de 2021 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
Tipo de estudo
Intervencional
Inscrição (Real)
45
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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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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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O resfriamento não invasivo é aplicado à área de tratamento com taxa e duração de resfriamento definidas.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Number of Device and/or Procedure-Related Adverse Events
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Pre-treatment Images Correctly Identified.
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de fevereiro de 2014
Conclusão Primária (Real)
27 de junho de 2014
Conclusão do estudo (Real)
27 de junho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
4 de março de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2014
Primeira postagem (Estimativa)
7 de março de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de março de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de fevereiro de 2021
Última verificação
1 de setembro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZA13-005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Sim
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