An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post-procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 990
- 试验地点
- 113
- 主要终点
- Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization
研究概览
简要总结
This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:
- Pelvic and/or lower abdominal pain
- Abnormal uterine bleeding
- Surgical intervention (including "insert removal" and hysterectomy)
- Allergic, hypersensitivity, or autoimmune-like reactions
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who are at least 21 years of age;
- •Subjects of all weights will be included;
- •Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
- •For the Essure group only:
- •Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;
- •For the laparoscopic tubal sterilization group only:
- •Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.
排除标准
- •Subjects who are post-menopausal;
- •Subjects suspected of being or confirmed pregnant;
- •Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
- •Subjects uncertain about ending fertility;
- •Subjects with an active upper or lower genital tract infection;
- •Subjects with gynecologic malignancy (suspected or known);
- •Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
- •Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
- •Subjects with unexplained vaginal bleeding.
研究组 & 干预措施
ESSURE (BAY1454032)
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented.
干预措施: Blood draw (Procedure)
ESSURE (BAY1454032)
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented.
干预措施: ESSURE (BAY1454032) (Device)
Laparoscopic tubal sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
干预措施: Blood draw (Procedure)
Laparoscopic tubal sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
干预措施: Laparoscopic tubal sterilization (Procedure)
结局指标
主要结局
Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization
时间窗: Up to 60 months
All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Patient reported outcomes for pain interference
时间窗: Up to 60 months
Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Interference 8a´. Pain interference is assessed via questions and ranked across 5 levels from ´Not at all´ to ´Very much´.
Patient reported outcomes for centralized pain
时间窗: At baseline
Assessed with the Fibromyalgia Survey Questionnaire
Patient reported outcomes on media sources for their medical decisioning
时间窗: Up to 60 months
Assessed by Social Media questionnaire to elicit information about sources of influence on medical decisions.
Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization
时间窗: Up to 60 months
All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilization
时间窗: Up to 60 months
All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization arms
时间窗: Up to 60 months
All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Proportion of subjects undergoing invasive gynecologic surgery after Essure placement (excluding second placement attempts), including Essure removal compared to subjects undergoing invasive gynecologic surgery after laparoscopic tubal sterilization
时间窗: Up to 60 months
All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Patient reported outcomes for health status
时间窗: Up to 60 months
Medical Outcomes Study Short Form-36
Patient reported outcomes for pain intensity
时间窗: Up to 60 months
Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Intensity 3a´. Pain intensity is assessed via questions and ranked across 5 levels from ´No pain´ to ´Very severe pain´.
Patient reported outcomes for bleeding by AMSS
时间窗: Up to 60 months
Aberdeen Menorrhagia Severity Scale (AMSS) is used to characterize bleeding. AMSS is a questionaire consisting of 13 items giving a total score from 0 (least severe) to 42 points (most severe).
Patient reported outcomes for bleeding by intermenstrual bleeding questions
时间窗: Up to 60 months
Two questions used to characterize intermenstrual bleeding.
Patient reported outcomes on adverse events from device reports
时间窗: Up to 60 months
Assessed by questionnaires to actively solicit information on adverse events found in medical device reporting (MDR) reports with Essure and control potential bias in adverse event reporting.
次要结局
未报告次要终点