In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Grade ≥2 vaginal mucosal trauma
研究概览
简要总结
The goal of this clinical trial is to learn if the Livi postcoital tampon device is safe for repetitive use in sexually active women aged 18 years and older. The main question it aims to answer is:
Does using the Livi device three times in a row cause any visible vaginal mucosal trauma? How much pain or discomfort do participants experience during insertion and removal?
Researchers will not compare the Livi device to another product because this is a single-arm safety study.
Participants will:
- Insert and remove the Livi device three times consecutively during one clinic visit
- Undergo a baseline speculum exam and digital colposcopy exams after each device removal to check vaginal tissue
- Complete a 24-hour follow-up via e-diary or phone call to report pain, spotting, or other symptoms
- Report any unsolicited symptoms for 7 days after use
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active women aged ≥18 years
- •Able and willing to comply with all study procedures
- •Able to provide written informed consent
排除标准
- •Current pregnancy or within 6 weeks postpartum
- •Symptomatic vaginal infection, lesion, or vulvovaginal discomfort at baseline
- •Known allergy to any component of the study device
- •Pelvic or vaginal surgery within the past 6 weeks
- •Any medical or psychological condition that, in the investigator's opinion, may interfere with participation or safety
研究组 & 干预措施
Livi Device Safety Evaluation
Participants will insert and remove the Livi device three times consecutively during a single clinic visit.
干预措施: Livi Postcoital Tampon Device (Device)
结局指标
主要结局
Incidence of Grade ≥2 vaginal mucosal trauma
时间窗: Immediate post-use (within 5 minutes of device removal)
Incidence of Grade ≥2 vaginal mucosal trauma assessed immediately after device removal via digital colposcopic examination. Mucosal trauma defined as: Grade 2 (Moderate): Abrasion \>5 mm or multiple foci totaling \>10 mm; pinpoint bleeding stopping spontaneously. Grade 3 (Severe): Laceration or bleeding requiring medical intervention.
次要结局
- Pain/discomfort during insertion/removal(During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr))
- Ease of use(During Visit 1 immediately following third device insertion)
- Spotting or pain within 24 hours post-use(24-hour (+/- 6hr) follow-up)
- Allergy and Hypersensitivity Responses(after each study device removal, and up to 7 days following visit 1)
研究者
Michael Ingber
Physician
Atlantic Health System