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

NCT04267562 | Completed Results FDA Device

• 1 other identifier: TD18036
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 5

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.

Conditions

Menorrhagia; Heavy Menstrual Bleeding; Heavy Uterine Bleeding

Keywords

excessive menstrual bleeding; menorrhagia; heavy menstrual bleeding; heavy uterine bleeding; menstrual disorders; menstruation disturbances

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (22)

• Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding

  Month 12 post-procedure

• Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding

  >Month 12 through Month 24 post-procedure

• 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 6 and Month 12 post-procedure

• Number of Trial Participants With Amenorrhea

  Month 24 post-procedure

Other Outcomes (3)

• Additonal Measure - Subject Self-Report of Pregnancy

  Month 36 post-procedure

• Additonal Measure - Contraception Status at Month 36

  Month 36 post-procedure

• Additonal Measure - Gynecologic Adverse Events

  Month 24 and Month 36 post-procedure

Study Arms (1)

Single-Arm, Open-Label Treatment with the Minitouch System

OTHER

Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System

Device: Minitouch System

Interventions

Minitouch System DEVICE

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

Single-Arm, Open-Label Treatment with the Minitouch System

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Enrollment is gender-based and is limited to females with a documented history of menorrhagia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroCube, LLC: lead

Study Sites (5)

CMB Research

Newburgh, Indiana, 47630, United States

Location

Amy Brenner, MD & Associates

Mason, Ohio, 45040, United States

Location

Women's Health Texas (Women Partners in Health)

Austin, Texas, 78705, United States

Location

AA ObGyn

Austin, Texas, 78758, United States

Location

OBGYN North

Austin, Texas, 78758, United States

Location

MeSH Terms

Conditions

Menorrhagia; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dinesh Mody
• Organization: MicroCube, LLC

m@minitouch.us

(510) 651-5000

Study Officials

• Scott G Chudnoff, MD, MSc

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

• Amy Brenner, MD

  Amy Brenner, MD & Associates, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: February 28, 2020
• Primary Completion: July 20, 2022
• Study Completion: December 31, 2023
• Last Updated: November 18, 2024
• Results First Posted: October 23, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)