Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions: A Multicenter Randomized Controlled Subject and Evaluator Blinded Pivotal Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 30
- 主要终点
- Freedom from intrauterine adhesions (IUA)
研究概览
简要总结
This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.
详细描述
This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects won't be told which group they were assigned. Primary outcome reviewed by blinded independent central review.
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
- •Premenopausal
- •Candidate for one of the following hysteroscopic procedures:
- •Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
- •Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease
- •Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
- •Subject is willing to undergo an SLH at the Week 8 visit.
- •Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
- •Subject has signed the IRB/EC approved informed consent
排除标准
- •Postmenopausal
- •IUD present at time of TCGP (unless removed before or during procedure)
- •Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
- •Planned intrauterine interventions post-TCGP through the Week 8 visit.
- •Recent intrauterine surgery within 6 weeks before the planned study procedure.
- •Pregnant (positive pregnancy test) or lactating.
- •Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies.
- •Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection.
- •Use of systemic corticosteroids within 1 week of study procedure.
- •Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
- •Known allergy to FD&C No.1 dye or polyethylene glycol (PEG).
- •Known clotting defects or bleeding disorders.
- •Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
- •Participating or considering participation in a clinical trial of another investigational drug or device during this study.
研究组 & 干预措施
Transcervical Gynecological Procedure + Juveena Hydrogel
Transcervical Gynecological Procedure + Juveena Hydrogel
干预措施: Juveena Hydrogel System (Device)
Transcervical Gynecological Procedure + Juveena Hydrogel
Transcervical Gynecological Procedure + Juveena Hydrogel
干预措施: Transcervical Gynecologic Procedures (TCGP) (Procedure)
Transcervical Gynecological Procedure alone (standard of care)
Transcervical Gynecological Procedure alone (standard of care)
干预措施: Transcervical Gynecologic Procedures (TCGP) (Procedure)
结局指标
主要结局
Freedom from intrauterine adhesions (IUA)
时间窗: 8 weeks
Incidence of No IUA at second look hysteroscopy (SLH)
次要结局
- Severity of IUA(8 weeks)
- Freedom of IUA with superiority margin of 5% over control at IUA(8 weeks)