NCT04437680已完成不适用
Retrospective Chart Review Study of Patients Treated With Votiva Device
InMode MD Ltd.2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年6月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Participant satisfaction post treatment
研究概览
简要总结
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18years of age at the time of the procedure
- •patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.
- •At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments
排除标准
- •active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.
结局指标
主要结局
Participant satisfaction post treatment
时间窗: 4 weeks post treatment
• Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results \[ Time Frame: Baseline to 4 weeks post-treatment/s\]
次要结局
未报告次要终点
研究者
研究点 (2)
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