Evaluation of Adhesions Formation Using Conventional Third Generation Endometrial Ablation With and Without Postoperative Application of an Intrauterine Adhesion Barrier Film
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Safety endpoint 1.3: Assessment of cavity findings
研究概览
简要总结
Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
详细描述
The application of endometrial ablation (EA) has significantly increased in the past 10 years. It is an effective treatment for heavy menstrual bleeding with functional aetiology. However, the risk of post-ablative intracavitary scarring after EA is significant and can lead to long term complications, and the possible delay in diagnosing endometrial cancer. CLEAN is a prospective, multi-center, randomized, controlled, two arm pilot clinical trial. The objective is to compare the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier.
The study will be performed on women with heavy menstrual bleeding (menorrhagia) scheduled for thermal endometrial ablation with Novasure system (Hologic) A follow-up diagnostic hysteroscopy will be performed 4-8 weeks after the ablation procedure to determine the presence and severity of IUAs according to the American Fertility Society.
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with refractory heavy menstrual bleeding scheduled for endometrial ablation with Novasure system
- •Women 30 years old or older;
- •Subjects who are willing to provide a written informed consent as approved by the applicable Ethics Committee / IRB prior to participating in this clinical investigation.
- •Subjects who can comply with the study follow-up and other study requirements.
排除标准
- •Cavity length <4 or >8
- •Perforation during ablation procedure
- •Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- •Abnormal uterine cavity at the time of ablation according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
- •History of cervical or endometrial cancer
- •Active pelvic infection or history of pelvic peritonitis
- •Known contraindication or hypersensitivity to Womed Leaf component
- •Current participation in another clinical investigation that has not yet received the primary endpoint
- •Any other condition that makes participation in the study contrary to the patient's best interests.
结局指标
主要结局
Safety endpoint 1.3: Assessment of cavity findings
时间窗: 4-8 weeks after surgery
Qualitative description of the endometrial cavity (i.e. presence of viable endometrium vs cicatricial/fibrotic tissue...)
Safety endpoint 1.2: Assessment of cavity findings
时间窗: 4-8 weeks after surgery
Ability to adequately visualise the endometrium to evaluate for pathologic change
Serious adverse events
时间窗: 3 months after surgery
Number of Serious Adverse Events and Serious Device-related Adverse Events such as postablation syndrome.
Safety endpoint 1.1: Assessment of cavity findings
时间窗: 4-8 weeks after surgery
Ability to perform a biopsy anywhere within the uterine cavity
Efficacy endpoint: AFS scale; a discrete number
时间窗: 4-8 weeks after surgery
Focused on the intrauterine adhesion formation following Novasure (i.e. considering only extent of cavity involved and type of adhesions) Extent of IUA =\> 1 = less than 1/3 of the cavity involved and 4 = more than 2/3. Type of IUA =\> 1 = filmy and 4 = dense. Sum: 1 = very light adhesions and 12 = extremely severe adhesions obstructing the whole cavity.
次要结局
- Number of subjects for whom a second ablation is possible(4-8 weeks after surgery)
- Level of dysmenorrhea(Before surgery and after 3 months)
- Change in menstrual bleeding(3 months after surgery)
- Each component of AFS score at second look hysteroscopy(4-8 weeks after surgery)
- Binary rate of intrauterine adhesions on hysteroscopy(4-8 weeks after surgery)
- Level of patient satisfaction on ablation procedure(Immediately after the surgery)
- Number of patients complaints(3 months after surgery)
研究者
Remko P. Bosgraaf
Principal Investigator
Catharina Ziekenhuis Eindhoven