NL-OMON41262已完成不适用
A prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding. - Pivotal study
AEGEA Medical Inc.0 个研究点目标入组 18 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
- 18
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
- •1. Able to understand and has voluntarily signed and dated the IRB/EC approved informed
- •consent form (ICF) prior to initiation of any screening or study-specific procedures;
- •2. Female subject from (and including) age 30 to 50 years;
- •3. Self-reported history of heavy menstrual bleeding in at least 3 of the last 6 months prior to
- •4. Predictable cyclic menstrual cycles (consistent cycle duration days 21-35 days) over the
- •last 6 months;
- •5. Excessive uterine bleeding, as documented by the Pictorial Blood Loss Assessment
- •Chart (PBLAC), with a PBLAC score of *150 for one baseline cycle within three months
- •prior to the endometrial ablation procedure for women who:
- •* Had at least 3 prior months (documented) failed medical therapy; or
- •* Had a contraindication to medical therapy (e.g., oral contraceptive pills, NSAIDs,
- •failed D&C, iron, cox inhibitors, tranexamic acid, progestins); or
- •* Intolerant of medical therapy; or
- •* Refused medical therapy.
- •6. Pre-menopausal at enrollment as determined by FSH measurement *40 IU/L;
- •7. Normal PAP or ASCUS PAP with negative HR HPV, within the past year or at the time of
- •screening or ASCUS HPV positive/low grade SIL who have been appropriately evaluated
- •and managed;
- •8. Normal endometrial biopsy within the past 3 months or at the time of screening;
- •9. Willing to use reliable contraception through the initial 12 month time period following the
- •AEGEA endometrial ablation procedure. Acceptable methods include:
- •* Female surgical sterilization (bilateral tubal sterilization), if completed prior to
- •enrollment in the study
- •* Implantable contraceptive device (e.g., Essure® Birth Control or Adiana®
- •Permanent Contraception System) if the tubal occlusion confirmation test has
- •been completed and is satisfactory prior to enrollment in this study;
- •Vasectomy with semen analysis confirming no sperm present (based on subject
- •report) and subject has a stable monogamous relationship throughout the initial
- •12 month follow-up phase
- •* Barrier contraceptives combined with spermicidal agent
- •* Monthly cyclic hormonal contraception (allowing a monthly withdrawal period) if
- •the subject has used monthly cyclic hormonal contraception for *3 months prior
- •to enrollment and is willing to continue the same monthly cyclic hormonal
- •contraception through the initial 12 month follow-up phase. Note: subjects not
- •on monthly cyclic hormonal contraceptives for a minimum of 3 months prior to
- •enrollment must agree to not use any monthly cyclic hormonal contraceptive from
- •enrollment through the initial 12 month follow-up phase except for the use of
- •endometrial thinning agents prior to the endometrial ablation procedure.
- •However, such subjects must agree to use another acceptable method of birth
- •control as outlined above.
- •NOTE: Other than for purposes of endometrial thinning prior to the ablation procedure,
- •subjects must not use hormonal contraception continuously (in order to suppress the
- •menstrual cycle and thus not allow a withdrawal bleed) for the concomitant treatment of
- •menorrhagia. There should be no concomitant use of any medication intended to treat
- •menorrhagia.
- •10. Not currently taking any hormonal medication (e.g., estrogen, progestin) and have not
- •been using any hormonal medication for a minimum of three months prior to study
- •enrollment and ag
排除标准
- •1. Is pregnant as determined by urine or serum pregnancy test at screening or on day of
- •2. Desires future childbearing;
- •3. Presence of an intrauterine device/system (IUD/IUS) that the subject is unwilling to have
- •removed prior to or at the time of the ablation procedure. Note: Subjects using a
- •hormonal releasing IUD/IUS must have their device removed prior to ablation and then
- •have one complete menstrual cycle at which time the baseline PBLAC diary may be
- •completed. An IUD/IUS may not be re-inserted following ablation. The subject must
- •agree to rely on either a barrier method plus spermicide, or vasectomy through the initial
- •12 month follow-up phase, as outlined above in inclusion (9).
- •4. Previous endometrial ablation procedure;
- •5. Evidence of an active sexually transmitted infection (STI) as determined by screening
- •examinations or testing as required;
- •Evidence of active or recurrent chronic pelvic inflammatory disease (PID) as determined
- •by screening examination;
- •7. Active infection of the genitals, vagina, cervix, uterus or urinary tract, at the time of the
- •procedure, as detected by screening examination and patient symptoms;
- •8. Presence of active endometritis identified by clinical diagnosis;
- •9. Presence of bacteremia, sepsis or other active systemic infection confirmed by blood
- •10. Suspected or confirmed gynecologic malignancy within the last five years as confirmed
- •by histology;
- •11. Endometrial hyperplasia as confirmed by histology;
- •12. Known clotting defects or bleeding disorders (coagulopathy), based on patient history
- •unless excluded by appropriate hematological examination;
- •13. Currently on anticoagulant therapy;
- •14. Hemoglobin <8gm/dl or considered by the investigator to be at risk for requiring a blood
- •transfusion within 12 months;
- •15. Prior uterine surgery (except low transverse cesarean section) which could lead to
- •weakening of the uterine wall (e.g. transmural myomectomy or classical cesarean
- •16. Currently on medications that could thin the myometrial muscle such as long-term steroid
- •use (except inhaler or nasal therapy for asthma);
- •17. Severe dysmenorrhea that, in the opinion of the investigator, is secondary to
- •adenomyosis (AUB-A) or where adenomyosis is suspected/known by prior evaluation;
- •Note: Severe dysmenorrhea is defined as pain with menses that interferes with the
- •subject*s lifestyle and is unresponsive to over-the-counter (OTC) medications taken at the
- •usual dose.
- •18. Known uterine wall thickness of <1cm as measured by ultrasound;
- •19. Known bicornuate uterus;
- •20. Known uterine septum > 1/3 cavity length;
- •21. Known leiomyoma(s) that obstructs access to the uterine cavity or which prevents
- •distension as determined by vaginal ultrasound, SIS or hysteroscopy;
- •22. Known uterine and/or cervical polyps *1cm in diameter or length or which, in the opinion
- •of the investigator, contribute to the bleeding (AUB-P). Note: polyp removal will be
- •allowed during screening but subjects must complete 2 menstrual cycles and then be re-
- •evaluated against all inclusion and exclusion criteria prior to enrollment.
- •23. Known or suspected hydrosalpinx based on history or ultrasound at screening;
- •24. Known uterine length measurement of <6cm or >12 cm (external os to internal fundus);
- •25. Currently participating or
研究者
相似试验
进行中（未招募）
1 期
Clinical trial evaluating patients' ability to make an independent and safe decision regarding the use of the medicinal product indicated in the treatment of erectile dysfunction.MedDRA version: 21.1Level: LLTClassification code 10052003Term: Erectile dysfunction NOSSystem Organ Class: 100000004872Erectile DysfunctionEUCTR2020-002731-30-PLZaklady Farmaceutyczne Polpharma S.A.400
已完成
4 期
Clinical study for HemoRel-A® in Hemophilia A patientsCTRI/2018/05/013790Dr Savita Rangarajan44
已完成
不适用
A multicentre, randomised clinical trial to evaluate the efficacy of oral ciprofloxacin, oral tamsulosin, and the combination of oral ciprofloxacin and oral tamsulosin for the treatment of Chronic Prostatitis/Chronic Pelvic Pain SyndromeISRCTN85291415ational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIDDK, NIH) (USA)184
已完成
不适用
A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESSosteoarthritis of the shouldercuff tear arthropathy1002321310005944NL-OMON47760AMSA50
进行中（未招募）
不适用
Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsissevere sepsis / septic shockMedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2007-004333-42-DEFriedrich-Schiller-University of Jena