Lipodystrophy Clinical Trial
Official title:
Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
This is a multi-site, prospective, controlled, randomized, double blinded clinical trial. This study is designed to evaluate the safety and efficacy of a series of treatments using the Venus Versa Octipolar applicator. Up to 60 healthy subjects at 10 sites shall be recruited by the investigator from within the investigator's subject population. Subjects shall have abdomen circumference to reduce for the designated treatment area. Each subject will undergo 6 treatments at an interval of one treatment per week for six consecutive weeks. There will be a one month follow up which will occur 4 weeks after the 6th treatment. At the first treatment visit, the investigator will collect demographic and medical information and randomization will take place. Subjects have an equal opportunity to be selected for the treatment or the control group. The duration of the treatment session will be approximately 60 minutes. Expected immediate response includes temporary mild to moderate erythema and/or edema. Skin safety assessments will be conducted by the investigator after each treatment session and at the follow-up visit. Photography will be conducted at baseline, the beginning of 4th & 6th treatment and at 1 month follow up visit. Subjects will be asked to complete a questionnaire after each treatment and at the one month follow up visit. Circumference measurements will be conducted at base line, before each treatment and at follow up visit. The treatment will be considered successful if the treated area circumference, reduces by at least 2.5 cm. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05419037 -
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
|
||
| Recruiting |
NCT03059121 -
The Cleveland Cardiometabolic Cohort
|
||
| Completed |
NCT00656175 -
Raltegravir Therapy for Women With HIV and Fat Accumulation
|
Phase 2 | |
| Completed |
NCT00202241 -
The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS
|
N/A | |
| Completed |
NCT00006185 -
Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome
|
Phase 1 | |
| Recruiting |
NCT02262832 -
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
|
Phase 3 | |
| Completed |
NCT01679197 -
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
|
Phase 2 | |
| Completed |
NCT02647853 -
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT00715546 -
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy
|
Phase 1 | |
| Completed |
NCT00069004 -
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
|
N/A | |
| Completed |
NCT00025883 -
Leptin to Treat Lipodystrophy
|
Phase 2 | |
| Completed |
NCT00001142 -
Metabolism and Body Shape of Healthy Children and Children With Chronic Infections
|
N/A | |
| Active, not recruiting |
NCT02262806 -
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
|
Phase 2 | |
| Completed |
NCT02258685 -
Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
|
||
| Completed |
NCT00192621 -
Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects
|
Phase 4 | |
| Completed |
NCT00006190 -
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
|
Phase 4 | |
| Recruiting |
NCT05930106 -
Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management
|
N/A | |
| Completed |
NCT00004329 -
Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
|
N/A | |
| Recruiting |
NCT04656054 -
Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance
|
||
| Completed |
NCT00082628 -
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
|
Phase 3 |