A Prospective, Single-centre, Non-comparative Feasibility Investigation to Evaluate Performance and Safety of RemovAid ™ Retrieval Device When Used for Removal of Palpable Subdermal Contraceptive Rod Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- RemovAid AS
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Successful removal of implant
研究概览
简要总结
The safety and efficacy of a subdermal implant retrieval device (RemovAid) is investigated in a population of 25 women seeking removal of their palpable contraceptive implants.
The primary endpoint of the device is to evaluate the performance of the device, specifically its success rate in removing palpable contraceptive implants. The device shall be able to fixate at least 80% of palpable implants, and successfully remove at least 90% of these implants.
详细描述
Similar to the REVALID and REVALID02 investigations, the REVALID03 investigation aims to recruit a total of 25 women with a palpable contraceptive implant due for removal, in order to obtain at least 20 successful fixations.
The implant retrieval device aims to standardize and simplify the implant removal procedure. There is no comparator in the investigation. Descriptive data will be recorded, all recruited subjects will be exposed to the investigational medical device (IMD) The primary endpoint is the percentage of fixated implants that are successfully removed without the use of additional tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 18 or older
- •Willing to remove a palpable subdermal Implanon/ Nexplanon CI
- •Willing and able to give written informed consent for participation in the investigation
- •Willing to provide follow-up information according to the Clinical Investigators brochure
排除标准
- •Known allergy to local anaesthetic (lidocaine/lignocaine) or disinfectant (chlorhexidine).
- •Active skin lesion over the CI.
- •The Investigator considers the subject unlikely to comply with investigational procedures, restrictions and requirements.
- •Any contraindication for removal of the PI, as judged by the Investigator.
- •Any disorders or medications that might affect coagulation, as judged by the Investigator.
- •Any conditions suspected to affect healing or increase risk of infection (e.g. keloid tendency, diabetes or any upper arm dermatological condition that may affect upper arm healing)
结局指标
主要结局
Successful removal of implant
时间窗: 15 minutes
The percentage of fixated implants that are successfully removed by the device without the use of additional tools
次要结局
- Frequency, severity, causality and outcome of adverse events (AEs)(1 week)
- Pain during procedure: Visual Analogue Scale(15 minutes)
- Success of fixation of implant(5 minutes)
- Duration of procedure(25 minutes)
- Operators impression of the device(5 minutes)
- Subject satisfaction: 5- point scale(5 minutes)
- Technical functionality of device determined by an operators questionnaire(5 minutes)