Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 10
- 主要终点
- Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
研究概览
简要总结
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
详细描述
The EASE Clinical Trial a prospective, multi-center, single-arm (open-label), non-randomized, clinical trial of the safety and effectiveness of endometrial ablation with the Minitouch System versus the FDA identified objective performance criteria (OPC) for global endometrial ablation (GEA) devices. The goal of the trial is to support reasonable safety and effectiveness of the investigational product compared to currently FDA-approved GEA devices.
Only eligible participants will undergo the Minitouch procedure. Post-treatment follow-up occurs approximately 24-hours post-procedure (via phone call) and in-person office visits occur 2-weeks, 3, 6 and 12-months post-procedure. Additional longer term follow-ups occur (via phone call or in-person office visits) 24 and 36-months post-procedure. The expected length of participation is approximately 37 months (inclusive of one month for screening and 36-months of post-procedure follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Qualified participants must meet all of the following inclusion criteria.
- •Female age 30 to 50 years
- •Excessive menstrual bleeding due to benign causes
- •Uterine sounding depth measurement of 6.0 - 12.0 cm
- •A minimum uterine cavity length of 4.0 cm
- •A minimum PBLAC score of ≥ 150 for 1 menstrual cycle (obtained during screening) and must also have a documented history of excessive menstrual bleeding prior to study enrollment
- •Endometrial biopsy within 12 months prior to treatment procedure with no abnormal pathology
- •Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40 years
- •Patient agrees to use a reliable form of contraception during the study and to follow these requirements: (a) If a hormonal birth control method is used for contraception, the patient must have been on said method for ≥ 3 months prior to the onset of the screening menstrual cycle and agrees to remain on the same hormonal regimen through the initial 12-month post-treatment follow-up (pills, injections, patches, rings, implants); (b) Patient also agrees to not use hormonal birth control during the first 12-month post-treatment follow-up period if they were not using hormonal birth control during the 3 months prior to treatment
- •Ability to provide written informed consent
- •Patient is literate and clearly demonstrates understanding on how to use PBLAC after training
- •Patient agrees to the following during the study: (a) No initiation of hormonal contraception or any other medical intervention for bleeding; (b) Attend all follow-up exams through the 36-month follow-up timepoint; and (c) Exclusive use of study-provided sanitary products and submission of completed PBLAC diaries through the 12-month post-treatment follow-up
排除标准
- •Qualified participants must NOT meet any of the following exclusion criteria.
- •Pregnant, or desires to retain fertility
- •Current or documented history of endometrial hyperplasia
- •Active endometritis
- •Clinically significant or suspected adenomyosis indicated by patient complaints, imaging, or clinician's judgment
- •Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract
- •Active pelvic inflammatory disease
- •Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling to remove the IUD
- •Presence of an implantable contraceptive device (e.g., Essure®) protruding into the uterine cavity
- •Active sexually transmitted disease (STD) at the time of ablation
- •Presence of bacteremia, sepsis, or other active systemic infection
- •Currently on anticoagulants
- •Known clotting defects or bleeding disorders
- •Currently on medications that could thin the myometrium, such as long-term steroid use
- •Previous medical/surgical treatments, or has other conditions, that could lead to anatomic/pathologic weakness or thinning of the myometrium
- •Any general health, mental health or social situation which, in the opinion of the investigator, could represent an increased risk for the patient, or the ability of the patient to complete study requirements
- •Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis
- •Abdominal, pelvic or gynecological malignancy
- •Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I (CIN I)
- •Previous endometrial ablation procedure
- •Abnormal or obstructed, or perforated cavity as determined by investigator via standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography).
- •Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts the uterine cavity
- •Any patient who is currently participating or considering participation in any other research of an investigational drug or device
结局指标
主要结局
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
时间窗: Month 12 post-procedure
The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding.
Number of Trial Participants With Device or Procedure-related Serious Adverse Events
时间窗: Month 12 post-procedure
The primary safety endpoint is the incidence of device or procedure-related serious adverse events.
次要结局
- Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding(>Month 24 through Month 36 post-procedure)
- Number of Trial Participants With Amenorrhea(Month 36 post-procedure)
- Dysmenorrhea-related Pain Score(Baseline and Month 36 post-procedure)
- Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home(Baseline and Month 36 post-procedure)
- Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity(Baseline and Month 36 post-procedure)
- Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities(Baseline and Month 36 post-procedure)
- Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used(Day of Procedure (during the procedure))
- Procedure Details: Type of Setting in Which the Procedure Took Place(Day of Procedure (prior to the procedure))
- Procedure-related Pain Score(Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure)
- Procedure Details: Recovery Time(Day of Procedure (post-procedure, prior to discharge))