CoolSculpting of the Flank With Alternate Treatment Parameters
9 février 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
Type d'étude
Interventionnel
Inscription (Réel)
45
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V6JIZ6
- Arbutus Laser Centre
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-
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California
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Sacramento, California, États-Unis, 95816
- Laser & Skin Surgery Center of Northern California
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Texas
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Dallas, Texas, États-Unis, 75231
- Dallas Plastic Surgery Institute
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Un refroidissement non invasif est appliqué à la zone de traitement avec une vitesse et une durée de refroidissement définies.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Number of Device and/or Procedure-Related Adverse Events
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of Pre-treatment Images Correctly Identified.
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 février 2014
Achèvement primaire (Réel)
27 juin 2014
Achèvement de l'étude (Réel)
27 juin 2014
Dates d'inscription aux études
Première soumission
4 mars 2014
Première soumission répondant aux critères de contrôle qualité
4 mars 2014
Première publication (Estimation)
7 mars 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 février 2021
Dernière vérification
1 septembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZA13-005
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .