NL-OMON51498已完成3 期
Evaluation of adhesions formation using conventional third generation endometrial ablation with and without postoperative application of an intrauterine adhesion barrier film - CLEA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1.Patient with refractory heavy menstrual bleeding scheduled for endometrial
- •ablation with NovaSure system
- •2.Women 30 years old or older;
- •3.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.
- •4.Subjects who can comply with the study follow-up and other study
- •requirements.
排除标准
- •1. Cavity length <4 or >8
- •2. Perforation during the ablation procedure
- •3. Previous adhesiolysis procedure or diagnosis of Asherman's disease.
- •4. An abnormal uterine cavity at the time of ablation according to ESHRE
- •classification I to V, such as unicornis, bicornis, septate, duplex
- •5. Medical history of cervical or endometrial cancer
- •6. Active pelvic infection or medical history of pelvic peritonitis
- •7. An intrauterine device in situ
- •8. Known contraindication or hypersensitivity to PEO or PLA
- •9. Current participation in another clinical investigation that has not yet
- •received the primary endpoint
- •10. Any other condition that makes participation in the study contrary to the
- •patient*s best interests.
研究者
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