NL-OMON34001已完成不适用
A RANDOMISED CONTROLLED TRIAL COMPARING BALLOON ENDOMETRIAL ABLATION (THERMABLATE) VERSUS BIPOLAR ENDOMETRIAL ABLATION (NOVASURE) IN THE OUTPATIENT CLINIC WITH LOCAL ANESTHESIA - Thermablate vs Novasure under local anesthesia
Máxima Medisch Centrum0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
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 99(—)
入选标准
- •Refractory menorraghia ;Uterine sound measurement of 6.0 - 12 cm ;Failed, contraindicated or intolerance to conservative therapy. ;Menstrual Diary A minimum score of >150 for 1 months ;Willing to undergo the treatment under local anesthesia in the outpatient clinic
排除标准
- •3.2.2.1 Presence of bacteremia, sepsis, or other active systemic infection;3.2.2.2 Active or recurrent chronic pelvic inflammatory disease ;3.2.2.3 Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g., transmural myomectomy or classical cesarean section. Prior endometrial ablations.;3.2.2.4 Desire to preserve fertility ;3.2.2.5 Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) ;3.2.2.6 Suspected or confirmed uterine malignancy or confirmed uterine malignancy within the last five years as confirmed by histology );3.2.2.7 Endometrial hyperplasia as confirmed by histology ;3.2.2.8 Unaddressed cervical dysplasia;3.2.2.9 Elevated FSH levels consistent with ovarian failure ( > 40 IU/ml) ;3.2.2.10 Active sexually transmitted disease
研究者
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