Patient Discomfort With a Novel Suction Based Cervical Retractor Compared to the Traditional Cervical Tenaculum
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pain Intensity Measure 100 point visual analogue scale
研究概览
简要总结
This study will test a suction-based method of engaging the cervix. Bioceptive has developed a device that more gently and atraumatically attaches to the cervix with no bleeding. This novel attachment mechanism may diminish pain and discomfort. Pre-clinical testing has been performed on the device including testing on synthetic uterine models, human cadavers, and human uteri immediately post-hysterectomy (Utah IRB # 00059096). Results from these efforts have shown effective attachment to the cervix and the ability for the device to maintain suction throughout a procedure atraumatically. This study proposes to introduce this minimal risk device in a clinical setting to determine the response of women undergoing gynecologic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects presenting for IUD insertion or endometrial biopsy
- •Able to consent for study in English or Spanish
排除标准
- •Post-menopausal
- •Current pregnancy
- •Cervical abnormalities (cervical polyp, cervical lesion, or irregularity)
- •Use of narcotics or Benzodiazepines prior to procedure
研究组 & 干预措施
Standard Cervical Tenaculum
Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
干预措施: Endometrial biopsy (Procedure)
Standard Cervical Tenaculum
Single tooth tenaculum, pierces the tissue of the cervix to allow provider to stabilize and place traction on the cervical cal/uterus
干预措施: Intrauterine device (IUD) insertion (Device)
Bioceptive Cervical Retraction Device
Suction based method for stabilizing the cervix and uterus. Achieves suction 360 degrees around cervical os creating a portal through which instruments can be passed into the cervical canal and uterus. Provider can still place traction on uterus with this device just as with tenaculum.
干预措施: Endometrial biopsy (Procedure)
Bioceptive Cervical Retraction Device
Suction based method for stabilizing the cervix and uterus. Achieves suction 360 degrees around cervical os creating a portal through which instruments can be passed into the cervical canal and uterus. Provider can still place traction on uterus with this device just as with tenaculum.
干预措施: Intrauterine device (IUD) insertion (Device)
结局指标
主要结局
Pain Intensity Measure 100 point visual analogue scale
时间窗: 1 day
Pain recorded by patient during the procedure and one day following via 100 point visual analogue scale. (0 = none, 100 = worst imaginable)
次要结局
- Procedural Satisfaction Patient records level of satisfaction with the procedure (Very Unsatisfied, Unsatisfied, Neutral, Satisfied, Very Satisfied)(< 1 hour)