Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness

STATUS

Recruiting
participants needed

126
sponsor

MicroCube, LLC

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Updated on 19 February 2024

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cavity

follicle stimulating hormone

hormonal contraception

menorrhagia

endometrial ablation

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).

Details

Condition	Menorrhagia, Hypomenorrhea, Heavy Uterine Bleeding
Age	30-50 years
Treatment	Minitouch System
Clinical Study Identifier	NCT04267562
Sponsor	MicroCube, LLC
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
Exclusion Criteria
	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

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness