Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Length of incision used for the removal of the single rod contraceptive implant device
研究概览
简要总结
This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently using Nexplanon and requesting removal
- •Qualifies for outpatient removal
- •Ability to understand and sign informed consent
排除标准
- •Pregnancy
- •Any rashes or skin conditions around the insertion site
- •Known allergy to lidocaine
- •Known allergy to biocompatible plastics or stainless steel
结局指标
主要结局
Length of incision used for the removal of the single rod contraceptive implant device
时间窗: During the intervention/procedure/surgery
This will be recorded for both groups.
Time to remove the contraceptive implant device
时间窗: During the intervention/procedure/surgery
The amount of time that it takes to remove the contraceptive implant will be noted for both groups.
次要结局
- Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive(During the intervention/procedure/surgery)
研究者
Carrie Bell, MD
Associate Professor of Obstetrics and Gynecology
University of Michigan