- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02939105
CoolSculpting Treatment in the Upper Arms (ARM)
DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V6E 4M3
- Pacific Dermaesthetics
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria
- Male or female subjects > 22 years of age and < 65 years of age.
- Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% in the preceding month.
- Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
- Subject has read and signed the study written informed consent form.
Exclusion Criteria
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
- History of prior surgery in the arms.
- Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
- Currently taking or has taken diet pills or weight control supplements within the past month.
- Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
- Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
- Pregnant or intending to become pregnant in the next 5 months.
- Lactating or has been lactating in the past 6 months.
- Unable or unwilling to comply with the study requirements.
- 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
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 Treatment in the Upper Arm
Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures. The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area. |
The CoolSculpting device will be used to perform treatments.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of Correctly Identified Pre-treatment Photos
Délai: 12 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.
Reviewers are practicing dermatologists or plastic surgeons.
All reviewers will be blinded to post-treatment vs. baseline untreated area.
The order in which images are 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 treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.
The expected success rate is 70% correct identification by 2 out of 3 reviewers.
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12 weeks post-final treatment
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Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
Délai: Enrollment through12 weeks post-final treatment
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The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period.
Investigators assessed each adverse event to determine if there was relationship to the study device or procedure.
Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.
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Enrollment through12 weeks post-final treatment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jason Rivers, MD, Pacific Dermaesthetics
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ZA16-005
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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 .
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