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
- 19
- 试验地点
- 2
- 主要终点
- Successful removal of implant .
研究概览
简要总结
There are no implant removal devices on the market by any manufacturer. Overall, the RemovAid™ combines the features of fixation, incision and extraction. This combination of functions has not previously been combined in a single device.
The investigators wish to perform this pilot clinical investigation with the aim to demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and effectively facilitate implant removal. Other aims are to show that the IMD have the potential to reduce procedure length variability, reduce procedural complexity and reduce the need for additional procedural equipment related to CI removal procedures, without causing any harm to the subject.
详细描述
Detailed Description:
Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s. They are advocated as a safe and effective method of contraception, and are included on the WHO's Essential Medicines list.
CI manufacturers have focused intense efforts on making insertion of CIs easier, but have largely left CI removals untouched and at the mercy of the various service providers. Different introducers and trocars are available for use with the different CI systems available internationally, and a second generation, single-use trocar is supplied with the Nexplanon® implant system available in Sweden. This second generation trocar has reduced the number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing minor surgical procedures through the use of dedicated medical devices.
The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on scalpels, forceps and general surgical skills from the service provider. Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal device is found on the commercial market.
Removal of palpable subdermal implants is generally a simple, minor surgical office procedure. However, the procedure for implant removal requires more training and skill than the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden movement by the client causing inadvertent deeper penetration, in which case any underlying structure could be affected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 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)
研究组 & 干预措施
RemovAid arm
New IMD Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.
干预措施: RemovAid device (Device)
结局指标
主要结局
Successful removal of implant .
时间窗: 15 minutes
Percentage of fixated implants that were successfully removed without the use of additional tools
次要结局
- Frequency, severity, causality and outcome of adverse events (AEs)(1 week)
- Pain during procedure(5 minutes)
- Success of fixation of implant(5 minutes)
- Duration of procedure(25 minutes)
- Technical functionality of device determined by an operators questionnaire(5 minutes)
- Operators impression of the device(5 minutes)
- Subject satisfaction(Time Frame: 5 minutes)