ESS505 Pre-hysterectomy Protocol: Safety and Short Term Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation
研究概览
简要总结
This study has been designed to evaluate an investigational model of the Essure System for Permanent Birth Control. The investigational device is designed to offer all the advantages of the currently approved device. In addition, the investigational device offers immediate, permanent contraception without a three-month waiting period or 90-day confirmation test. This study has been designed to evaluate the effectiveness of the investigational device in causing tubal occlusion from insert placement through three months of wearing.
详细描述
This study has previously been posted by Conceptus, Inc. (US).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects who are scheduled to undergo a Laparoscopically Assisted Vaginal Hysterectomy (LAVH), Total Abdominal Hysterectomy (TAH), Total Vaginal Hysterectomy (TVH), Total Laparoscopic Hysterectomy (TLH) with Bilateral Total Salpingectomy or Bilateral Salpingo-oophorectomy (BSO), or Laparoscopic Supracervical Hysterectomy (LSH)
- •Subjects who are 18 years of age and older
- •Subjects who are able and willing to provide written informed consent
- •Subjects who agree to use a contraceptive method following Essure placement until the hysterectomy procedure
排除标准
- •Subjects with bilateral proximal tubal occlusion
- •Subjects who have undergone fallopian tube sterilization
- •Subjects with known endometrial or myometrial pathology which is likely to prevent access to the fallopian tube ostia
- •Subjects who are post-menopausal
- •Subjects with pelvic inflammatory disease (PID)
- •Subjects with gynecologic malignancy
- •Pregnancy or suspected pregnancy
- •Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement
- •Known allergy to contrast media
- •Any general health condition that may represent, in the opinion of the Investigator, an increased potential risk associated with participation
研究组 & 干预措施
ESS505-A (Essure, BAY1454033)
Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
干预措施: ESS505-A (Essure, BAY1454033) (Device)
ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
干预措施: ESS505 (Essure, BAY1454033) (Device)
ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)
Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
干预措施: ESS305 (Essure, BAY1454032) (Device)
结局指标
主要结局
Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation
时间窗: 60 minutes after insert placement
Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.
Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation
时间窗: 30 days after insert placement
Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation
时间窗: 60 days after insert placement
Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation
时间窗: 90 days after insert placement
Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.
次要结局
未报告次要终点