21 Clinical Trials for Various Conditions
The purpose of this feasibility study is to gain an initial assessment of the acute safety and performance of the Apsara Thermal Wand System in human facial tissue.
The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.
Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each follow-up visit.
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
The purpose of this study is to evaluate the Ulthera® System for obtaining lift and tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or submental skin laxity when increased density treatment is applied.
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.
This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.
Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.
Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.
All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained at each follow-up visit.
Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
Prospective, non-randomized, multi-center, pivotal clinical trial