Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of adverse recorded in participants after injection
研究概览
简要总结
Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures.
The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency.
Currently, many products can be used as an injectable in the vocal fold to correct glottic insufficiency such as carbomethycellulose, hyaluronic acid, collagen derivatives and calcium hydroxyapatite amongst others. An ideal injectable would not impair the fibroelastic property of the vocal fold tissues and would integrate within the tissue of the vocal fold. Since Renuva has the property of stimulating adipogenesis by using growth factor and collagen, the investigators believe it could represent a good option in terms of safety and efficacy for vocal fold augmentation.
This study will assess the safety and efficacy of Renuva as a vocal fold injectable to treat glottic insufficiency.
详细描述
Background/Significance:
Vocal cord injection augmentation is commonly used to treat glottal insufficiency. Various materials are used for injection augmentation including autologous fat, hyaluronic acid, collagen, carboxymethylcellulose, and calcium hydroxyapatite. However, all of the current injection choices have individual limitations such as temporary effect, unpredictability due to variable resorption by the body, unfavorable mechanical properties, and challenging handling attributes. Hence, there is a need for a more ideal injection augmentation substance that is biocompatible, nonimmunogenic, able to traverse small gauge needles, easy to use, and facilitates long term or permanent effect when desired.
Intervention:
Unilateral injection augmentation with allograft adipose matrix injectable. Renuva ®, is commonly used as in injectable material in plastic surgery for treatment of small cosmetic irregularities. The injectable stimulates adipogenesis using key matrix proteins including collagen IV, collagen VI, FGF-2, and VEGF. The injectable does not contain any lipids, cellular fragments, or DNA content. In vitro and in vivo demonstrate that the injectable can stimulate adipose tissue generation. Given this important quality, allograft adipose matrix may provide vocal fold bulk for a longer period of time with favorable viscoelastic properties which would make it a desirable agent for vocal fold augmentation.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥ 18 years old
- •Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset
- •Willingness to partake in study and follow-up as documented by signed informed consent
排除标准
- •History of allergy/hypersensitivity to lidocaine or amide-based anesthetics
- •Pregnancy
- •Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
- •Comorbid known laryngeal conditions including but not limited to vocal fold scar, vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for optimal treatment
- •History of laryngeal surgery
- •Life expectancy of less than 6 months
结局指标
主要结局
Number of adverse recorded in participants after injection
时间窗: 18 months
Monitoring of adverse events during the study period for each participant receiving a vocal fold injection with Renuva
次要结局
- Voice outcomes as reported by patient questionnaire(18 months)
- Score on VALI - Voice Vibratory Assessment of laryngeal imaging(18 months)
- Dyspnea Index as measured by patient questionnaire(18 months)
研究者
Karla O'Dell
Assistant Professor
University of Southern California