Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device with a Follow-up of 3 Years.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Positioning of the ReLARC IUD
研究概览
简要总结
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.
This multicentre, open-label study will take place at the Women's Clinic of Ghent University Hospital in Belgium (International Coordinating Centre) and at the University Hospital AOU Federico II of Naples in Italy.
Primary aim:
To evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations.
Providing no complications develop, participants will remain in the study for 3 years. 120 women will be enrolled.
详细描述
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.
This multicentre, open-label study will take place in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in the University Hospital AOU Federico II of Naples in Italy.
Primary aim:
To evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations.
Providing no complications develop, participants will remain in the study for 3 years. 120 women will be enrolled. During the screeningsvisit the physician will introduce the trial. During the enrolment visit, the patient will sign the informed consent if she agrees to participate. During the insertion visit, the IUD will be placed, the correct location of the device will be determined, the ease of ReLARC insertion and hysteroscope insertion will be measured, the learning curve of the insertion will be registered and the pain score of the patient will be registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy
- •Be willing to come back for the follow-ups
- •Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion
- •Sign a written informed consent
- •Fundus thickness should be 11mm or more
排除标准
- •T and Y shaped uterus
- •U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation)
- •Complete septate U2b uterus
- •Bicorporal U3-U6 uterus
- •Injectables contraceptive use in the last 6 months
- •The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out)
- •Intrauterine fibroids (intra-mural, intracavitary or submucosal)
- •Cancer or other disease of the uterus
- •Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject
- •Blood clotting disorders
- •Intrauterine polyps
- •Subjects receiving corticosteroid therapy or immunosuppressive drugs
- •Morbus Wilson
- •Pregnancy
结局指标
主要结局
Positioning of the ReLARC IUD
时间窗: 3 years
To evaluate the position of the ReLARC® IUD to confirm the succesful placement of the IUD with the ReLARC inserter during every follow-up visit.
次要结局
- Ease of removal(7 years)
- Removal rate(7 years)
- Pain at removal(7 years)
- Ease of insertion(During Insertion visit)
- Expulsion rate(7 years)
- Pain score(During Insertion visit)
- Learning curve of ReLARC insertion(During Insertion visit)
- patient satisfactory(3 years after insertion)
- Uterine cavity transverse diameter(During insertion visit)