Clinical trial NCT04267562: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
Official title: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Heavy Menstrual Bleeding
Heavy Uterine Bleeding
Keywords: excessive menstrual bleeding
menorrhagia
heavy menstrual bleeding
heavy uterine bleeding
menstrual disorders
menstruation disturbances
Lead sponsor: MicroCube, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 219
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Key Inclusion Criteria: Qualified participants must meet all of the following inclusion criteria.

1. Female age 30 to 50 years
2. Excessive menstrual bleeding due to benign causes
3. Uterine sounding depth measurement of 6.0 - 12.0 cm
4. A minimum uterine cavity length of 4.0 cm
5. 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
6. Endometrial biopsy within 12 months prior to treatment procedure with no abnormal pathology
7. Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40 years
8. 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
9. Ability to provide written informed consent
10. Patient is literate and clearly demonstrates understanding on how to use PBLAC after training
11. 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

Key Exclusion Criteria: Qualified participants must NOT meet any of the following exclusion criteria.

1. Pregnant, or desires to retain fertility
2. Current or documented history of endometrial hyperplasia
3. Active endometritis
4. Clinically significant or suspected adenomyosis indicated by patient complaints, imaging, or clinician's judgment
5. Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract
6. Active pelvic inflammatory disease
7. Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling to remove the IUD
8. Presence of an implantable contraceptive device (e.g., Essure®) protruding into the uterine cavity
9. Active sexually transmitted disease (STD) at the time of ablation
10. Presence of bacteremia, sepsis, or other active systemic infection
11. Currently on anticoagulants
12. Known clotting defects or bleeding disorders
13. Currently on medications that could thin the myometrium, such as long-term steroid use
14. Previous medical/surgical treatments, or has other conditions, that could lead to anatomic/pathologic weakness or thinning of the myometrium
15. 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
16. Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis
17. Abdominal, pelvic or gynecological malignancy
18. Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I (CIN I)
19. Previous endometrial ablation procedure
20. Abnormal or obstructed, or perforated cavity as determined by investigator via standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography).
21. Intramural or subserosal myomas \> 3 cm in size, or any myoma that distorts the uterine cavity
22. Any patient who is currently participating or considering participation in any other research of an investigational drug or device

Primary outcomes:
measure: Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
timeFrame: Month 12 post-procedure
measure: Number of Trial Participants With Device or Procedure-related Serious Adverse Events
timeFrame: Month 12 post-procedure
Secondary outcomes:
measure: Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
timeFrame: Month 12 post-procedure
measure: Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
timeFrame: >Month 12 through Month 24 post-procedure
measure: Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
timeFrame: >Month 24 through Month 36 post-procedure
measure: Number of Trial Participants With Amenorrhea
timeFrame: Month 6 and Month 12 post-procedure
measure: Number of Trial Participants With Amenorrhea
timeFrame: Month 24 post-procedure
measure: Number of Trial Participants With Amenorrhea
timeFrame: Month 36 post-procedure
measure: Dysmenorrhea-related Pain Score
timeFrame: Baseline, Month 6 and Month 12 post-procedure
measure: Dysmenorrhea-related Pain Score
timeFrame: Baseline and Month 24 post-procedure
measure: Dysmenorrhea-related Pain Score
timeFrame: Baseline and Month 36 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
timeFrame: Baseline, Month 6 and Month 12 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
timeFrame: Baseline and Month 24 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
timeFrame: Baseline and Month 36 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
timeFrame: Baseline, Month 6 and Month 12 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
timeFrame: Baseline and Month 24 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
timeFrame: Baseline and Month 36 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
timeFrame: Baseline, Month 6 and Month 12 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
timeFrame: Baseline and Month 24 post-procedure
measure: Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
timeFrame: Baseline and Month 36 post-procedure
measure: Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used
timeFrame: Day of Procedure (during the procedure)
measure: Procedure Details: Type of Setting in Which the Procedure Took Place
timeFrame: Day of Procedure (prior to the procedure)
measure: Procedure-related Pain Score
timeFrame: Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure
measure: Procedure Details: Recovery Time
timeFrame: Day of Procedure (post-procedure, prior to discharge)
Other outcomes:
measure: Additonal Measure - Subject Self-Report of Pregnancy
timeFrame: Month 36 post-procedure
measure: Additonal Measure - Contraception Status at Month 36
timeFrame: Month 36 post-procedure
measure: Additonal Measure - Gynecologic Adverse Events
timeFrame: Month 24 and Month 36 post-procedure
Locations:
city: Newburgh
country: United States
facility: CMB Research
state: Indiana
city: Mason
country: United States
facility: Amy Brenner, MD & Associates
state: Ohio
city: Austin
country: United States
facility: Women's Health Texas (Women Partners in Health)
state: Texas
city: Austin
country: United States
facility: AA ObGyn
state: Texas
city: Austin
country: United States
facility: OBGYN North
state: Texas
Study officials:
affiliation: Maimonides Medical Center
name: Scott G Chudnoff, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Amy Brenner, MD & Associates, LLC
name: Amy Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References: