Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
1 octobre 2020 mis à jour par: Zeltiq Aesthetics
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures.
The curvature of interest is typical of individuals who are relatively thin with a small body frame.
Type d'étude
Interventionnel
Inscription (Réel)
25
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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California
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Pleasanton, California, États-Unis, 94588
- Innovation Research Center
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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 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
- 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, abdominoplasty, 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 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: Zeltiq System Treatment Group
Individuals with sharp flank curvatures were treated on one (1) flank with the Zeltiq CoolSculpting System and the CoolCurve+ applicator at protocol-defined temperatures and durations.
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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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Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
Délai: 8 weeks and 16 weeks post final treatment
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Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
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8 weeks and 16 weeks post final treatment
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Change in Fat Layer Thickness When Compared to Untreated Control
Délai: 16 weeks post final 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 contralateral untreated 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 the untreated control from the change in treated area to remove the influence of weight variations.
Results indicate the mm of fat layer reduction in the treated area.
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16 weeks post final 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 final 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 of the treated areas.
Reviewers will be practicing dermatologists or plastic surgeons.
All 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.
Results reflect the proportion of correctly identified images.
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16 weeks post final treatment
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Subject Satisfaction Questionnaire
Délai: 16 weeks post final 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.
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16 weeks post final treatment
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Additional Safety Evaluation
Délai: Enrollment though 16 weeks post final treatment
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The number of device or procedure-related adverse events will be evaluated.
The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events.
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Enrollment though 16 weeks post final 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: Eric Bachelor, MD, Innovation Research Center
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)
29 mars 2012
Achèvement primaire (Réel)
29 août 2012
Achèvement de l'étude (Réel)
30 septembre 2013
Dates d'inscription aux études
Première soumission
16 avril 2012
Première soumission répondant aux critères de contrôle qualité
16 mai 2012
Première publication (Estimation)
17 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 octobre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 octobre 2020
Dernière vérification
1 octobre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZA12-005
Plan pour les données individuelles des participants (IPD)
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NON
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