Safety and Efficacy of a Suction Cervical Stabilizer Compared to the Standard Tenaculum for Intrauterine Procedures in the Clinic Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Patient-perceived Pain
研究概览
简要总结
To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •• Age 18 years or older
- •Speaks and reads in English
- •Able to consent on their own
- •Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
- •Cervix at least 26 mm in diameter
- •Twenty providers performing this procedure
排除标准
- •• Vaginal bleeding of unknown origin
- •Cervix less than 26 mm in diameter
- •Nabothian cyst on anterior lip of cervix
- •Cervical myomas
- •Cervical abnormalities
结局指标
主要结局
Patient-perceived Pain
时间窗: Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion)
Patients will be asked to rate their pain using the Numeric Rating Scale, a pain screening tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Participants fill out their survey once the procedure and clinical appointment is concluded.
次要结局
- Provider-perceived Bleeding(Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion))
- Provider-perceived Ease of Use(Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion))
- Provider-perceived Satisfaction(Immediately after intrauterine procedure and scheduled appointment is complete (approx. 5-10 minutes after procedure completion))
研究者
Alissa M Conklin
Assistant Professor of Clinical Obstetrics and Gynecology
Indiana University