Minimally Invasive Active Release of Septa Bands for Cellulite and Connective Tissue Release for Fibrosis Treatment in Body Contouring Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Serious Adverse Events Incidence
研究概览
简要总结
This prospective study aims to evaluate the safety and effectiveness of AVELI for reducing cellulite and fibrotic tissue in patients undergoing High-Definition Liposculpture, exploring if AVELI improves the aesthetic outcomes, and reduced the clinically evident cellulite and/or fibrosis.
The main questions this study seeks to answer are:
- Does AVELI safely reduce cellulite and fibrotic tissue without causing serious adverse events?
- How effective is AVELI in improving patient-reported outcomes and aesthetic appearance?
Through this study, the study team aims to evaluate the safety and effectiveness of AVELI.
The study procedures include:
- Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, and satisfaction scores.
- All patients will undergo the standardized High-Definition Liposculpture technique, with AVELI applied to all identified cellulite and/or fibrosis release.
- Photographic and 3D imaging preoperatively and at follow-ups (1, 3, 6, and 9 months).
详细描述
Study design: Interventional prospective cohort study, non-randomized, non-controlled, no masking.
Ethical Considerations:
- IRB Approval: The study will adhere to the Declaration of Helsinki principles and will be approved by an Institutional Review Board (IRB).
- Informed Consent: Participants will be provided comprehensive information about study procedures, risks, and benefits, and written consent will be obtained.
- Data Confidentiality: All participant data will be anonymized and securely stored.
Eligible patients will be approached, the study aims, objectives, procedures, and voluntary participation will be explained. In case patient consent to participate, a written informed consent will be signed. The patients will be comprehensively evaluated by the plastic surgeon, and assigned to a group based on their individual physical evaluation findings: Cellulite Group, Fibrosis Group, Fibrosis and Cellulite Group.
Study Locations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was feasible for this study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing HDL between 18 and 60 years old.
- •Non-gender specific.
- •American Association of Anesthesiologist Risk Assessment (ASA) ≤
- •Body Mass Index (BMI) ≥20 and ≤ 32 kg/m
- •Patients with any degree of clinically evident cellulite in any body area.
- •Patients with prior liposuction procedures with any degree of fibrosis in any body area.
- •Patients undergoing additional procedures such as, but not limited to: Rhinoplasty, Mammaplasty, Mastopexy, mini tummy tuck, full tummy tuck, brachioplasty, thighplasty, fat grafting. The procedure could not be related to the treatment of fibrosis or cellulite.
排除标准
- •Patients requiring SQ fat grafting for the amendment of any contour irregularity.
- •Patients requiring other devices/drugs for skin contraction and/or cellulite treatment for the next 6 months (RF, US, Enzymes, etc.).
- •Patients undergoing Face Lift procedures.
- •Patients with any history of abnormal scarring and/or hypertrophic scars and or keloids.
- •Patients with Caprini score ≥
- •Patients with past medical history of connective tissue disease with active disease and/or recent relapse.
- •Patients with past medical history thromboembolic disease or any other condition with an increased risk of coagulopathy (i.e., SLE, RA, APS).
- •Patients using aspirin or any anticoagulant within 14 days and 5 days prior to surgery, respectively.
- •Patients with a PMH of epilepsy or any epileptic syndrome and or vascular disease.
- •Patients with any chronic disease non-compliant with treatment or non-adequately controlled.
- •Positive pregnancy test or planning on getting pregnant in the next 6 months.
- •Patients with fever or any other symptoms/signs of infection.
- •Active smokers or chronic smokers with recent quit (≤ 4-8 weeks).
- •Patients with prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 times baseline.
研究组 & 干预措施
Cellulite group (CG)
Patients with any degree of clinically evident cellulite undergoing HDL + AVÉLI treatment for Cellulite.
干预措施: AVELI (Device)
Fibrosis Group (FG)
Patients with any degree of fibrosis undergoing non-primary HDL + AVÉLI release of fibrotic tissue.
干预措施: AVELI (Device)
Fibrosis and Cellulite Group (FCG)
Patients with any degree of clinically evident cellulite AND fibrosis undergoing non-primary HDL + AVÉLI treatment for both.
干预措施: AVELI (Device)
结局指标
主要结局
Serious Adverse Events Incidence
时间窗: 30 days
Incidence of intervention-related serious adverse events (SAE). SAE were defined as any adverse events that met one or more of the following criteria: required hospital care, required additional medical intervention or treatment, produced any disability, were classified as life-threatening, or resulted in the death of the patient.
Patient Satisfaction Scores
时间窗: 6 months
Patient-reported satisfaction scores measured using Global Aesthetic Improvement Scale (GAIS) for the reduction of cellulite and/or fibrosis. The GAIS is a standardized scale used primarily in cosmetic and dermatological treatments to assess the overall aesthetic improvement of a patient after a procedure. It consist of three questions: * how do you feel about your appearance after surgery? Possible answers: Very much improved, much improved, slightly improved, no change. * Are you satisfied with the surgery? Very satisfied, satisfied, not satisfied. * Would you recommend the surgical procedure? Possible answers: Yes, perhaps, no.
Photographic aesthetic outcomes analysis
时间窗: One month, three months, six months, and nine months
Through 3D camera photos and photographic software, an analysis will objectively calculate the differences between preoperative contour defects (fibrosis and/or cellulite) and postoperative improvement.
次要结局
未报告次要终点
研究者
Alfredo Hoyos
MD, Plastic Surgeon | Total Definer
Total Definer Research Group