CONFORM: Rotational Fractional Resection for Submental Contouring

Status Completed

Clinical Trial Summary

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Clinical Trial Description

This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03407313
Study type	Interventional
Source	Recros Medica, Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 8, 2018
Completion date	April 23, 2019

View Details

See also
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	`NCT00006185` - Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome	Phase 1
Completed	`NCT00202241` - The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS	N/A
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