A Pilot Study of the Renuvion APR System When Used as an Adjunct Procedure In Gynecomastia Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Analysis of Bilateral Occurrence of Adverse Events
研究概览
简要总结
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States.
详细描述
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States.
At baseline, the grade of gynecomastia was recorded by side, male chest measurements will be taken, and pre-surgery photographs taken in the frontal, lateral, and oblique views.
The gynecomastia surgery and Renuvion APR System use were as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla was not allowed. The Renuvion APR System was used on one side only. The Renuvion treated side was randomized and the patient was blinded as to which side of the chest received Renuvion. Procedure data and adverse events were captured. Endermology was not allowed post-procedure. Post-procedure compression was used for 2-3 weeks with a standard compression vest for all subjects.
Follow-up images, grade of gynecomastia, and male chest measurements were taken at D30/D90/D180.
All images were assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects, ages 18 - 75 years old.
- •ASA Physical Status Classification System Class I and Class II subjects.
- •Clinical diagnosis of primary or secondary Gynecomastia.
- •Gynecomastia Rohrich Grade IIA or higher.
- •Symmetrical gynecomastia Rohrich grades.
- •Symmetrical chest measurements (no more than 3% variance between sides).
- •Scheduled for Gynecomastia surgery.
- •Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit.
- •Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
- •Absence of physical conditions unacceptable to the investigator.
- •Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
- •Willing to release rights for the use of study photos, including in publication.
- •Able to read, understand, sign, and date the informed consent.
排除标准
- •Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors.
- •Subjects presenting with ASA Physical Status Classification System Classes III or higher.
- •Gynecomastia Rohrich Grade I.
- •Non-symmetrical gynecomastia Rohrich grades.
- •Non-symmetrical chest measurements (more than 3% variance between sides).
- •Previous treatment or surgery in the breast area.
- •Active systemic or local skin disease that may alter wound healing.
- •Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
- •History of autoimmune disease (excluding Hashimoto's thyroiditis).
- •Known susceptibility to keloid formation or hypertrophic scarring.
- •Cancerous or pre-cancerous lesions in the area to be treated.
- •Possesses a surgically implanted electronic device (i.e. pacemaker).
- •Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- •Use of endermology post-procedure for the duration of the study.
- •Participation in any other investigational study within 30 days prior to consent and throughout study participation.
- •Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
结局指标
主要结局
Analysis of Bilateral Occurrence of Adverse Events
时间窗: Through Day 180
Analysis of bilateral occurrence of adverse events by study arm.
次要结局
- Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold(Day 30, 90, 180)
- Bilateral Analysis of Male Chest Measurements(Day 30, 90, 180)
- Bilateral Subject Global Aesthetic Improvement Scale(Day 30, 90, 180)
- Bilateral Patient Satisfaction Questionnaire(Day 30, 90, 180)
- Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers(Day 180)
- Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole(Day 30, 90, 180)
- Gland Tissue Removal by Number of Participants(Procedure)
- Bilateral Physician Global Aesthetic Improvement Scale(Day 30, 90, 180)
- Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification)(Procedure)