Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Comparative)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Patient-reported pain: Visual Analogic Scale
研究概览
简要总结
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up.
AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber.
The aim of our comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).
Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding pilot study is registered separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Single-blinded - Participants will be blinded towards the intervention used. Additionally, the type of device used will only be revealed to the practitioner after randomization, immediately prior IUD insertion.
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
- •Participants older than 18 years
- •Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
- •Participants able to provide informed consent as documented by signature with at least 24 hours of reflection time
- •Good understanding of written and oral speaking used at the centre where the study will be carried out.
排除标准
- •Participants who are contraindicated for the insertion of the IUD Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
- •Participants under use of excessive alcohol, narcotics or benzodiazepines prior to procedure
- •Participants who do not wish to be informed of a chance discovery
- •Participant receiving anaesthetics prior to IUD insertion procedure
- •Participants on anticoagulant medication
- •Participants under use of an analgesic (< 12 hours)
- •Previous cervical operation
- •Severe vaginal bleeding of unknown origin
- •Participant previously enrolled in this study
- •Cervix diameter smaller than 26 mm
- •Nabothian cyst
- •Cervical myomas
- •Cervical condylomas
- •Squamous intraepithelial lesion (Cervical dysplasia)
- •Cervical endometriosis
- •Cervical tears
- •A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
- •Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
- •Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
- •Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present
结局指标
主要结局
Patient-reported pain: Visual Analogic Scale
时间窗: 5 minutes after the end of the procedure
Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
次要结局
- The number of placement attempts before traction can be applied(During the procedure to insert the IUD which should last less than 5 minutes.)
- The number of spontaneous releases(During the procedure to insert the IUD which should last less than 5 minutes.)
- Assessment of the efficacy of the investigational device and its comparator by the practitioner(During the procedure to insert the IUD which should last less than 5 minutes.)
- Assessment of bleeding(During the procedure to insert the IUD which should last less than 5 minutes.)
- Assessment of adverse events(During the procedure to insert the IUD which should last less than 5 minutes.)
- Assessment of device deficiencies(During the procedure to insert the IUD which should last less than 5 minutes.)
- Identification of new risks(During the procedure to insert the IUD which should last less than 5 minutes.)