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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04267562
Other study ID # TD18036
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 28, 2020
Est. completion date December 2023

Study information

Verified date August 2023
Source MicroCube, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 219
Est. completion date December 2023
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 50 Years
Eligibility 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

Study Design


Intervention

Device:
Minitouch System
The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System

Locations

Country Name City State
United States AA ObGyn Austin Texas
United States OBGYN North Austin Texas
United States Women's Health Texas (Women Partners in Health) Austin Texas
United States Amy Brenner, MD & Associates Mason Ohio
United States CMB Research Newburgh Indiana

Sponsors (1)

Lead Sponsor Collaborator
MicroCube, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of =75) 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.
Month 12 post-procedure
Primary Number of Trial Participants With Device or Procedure-related Serious Adverse Events The primary safety endpoint is the incidence of device or procedure-related serious adverse events. Month 12 post-procedure
Secondary Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding. Month 12 post-procedure
Secondary Number of Trial Participants With Amenorrhea Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding) Month 6 and Month 12 post-procedure
Secondary Procedure-related Pain Score Procedure-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.
Timepoints:
Pre-procedure (on the day of, prior to the procedure) Discharge (post-procedure, prior to discharge) 24-hours post-procedure (18-48 hours post-procedure)
Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure
Secondary Dysmenorrhea-related Pain Score Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome. Baseline, Month 6 and Month 12 post-procedure
Secondary Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2):
Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Baseline, Month 6 and Month 12 post-procedure
Secondary Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3):
Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely
Baseline, Month 6 and Month 12 post-procedure
Secondary Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4):
Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely
Baseline, Month 6 and Month 12 post-procedure
Secondary Procedure Details: Type of Setting in Which the Procedure Took Place Secondary Outcome Measure - Setting in which the Minitouch Procedure took place Time frame: the type of setting is assessed on day of procedure, prior to the procedure Day of Procedure (prior to the procedure)
Secondary Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used Secondary Outcome Measure - Use of Cervical Dilator (Yes / No) Time frame: the need for using a cervical dilator is assessed on day of procedure, during the procedure Day of Procedure (during the procedure)
Secondary Procedure Details: Recovery Time Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge Day of Procedure (post-procedure, prior to discharge)
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