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MenorrhagiaNCT04267562

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

A study testing Minitouch System in people with Menorrhagia and Heavy Menstrual Bleeding, run by MicroCube, LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Minitouch System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
5 sitesUnited States
Study dates
28 Feb 2020to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Women's Health Texas (Women Partners in Health)

    Austin, Texas, 78705

  • AA ObGyn

    Austin, Texas, 78758

  • OBGYN North

    Austin, Texas, 78758

  • Amy Brenner, MD & Associates

    Mason, Ohio, 45040

  • CMB Research

    Newburgh, Indiana, 47630

Other trials in United States

About this study

Official title: Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)

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.

Read the 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).

Being tested
Minitouch System
Keywords
excessive menstrual bleeding, menorrhagia, heavy menstrual bleeding, heavy uterine bleeding, menstrual disorders, menstruation disturbances
Medical subject headings
Menorrhagia, Menstruation Disturbances

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minitouch SystemDevice

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

Study groups in NCT04267562
Study groupRoleWhat they receive
Single-Arm, Open-Label Treatment with the Minitouch SystemOtherEligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
Receives: Device: Minitouch System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 12 post-procedure

  2. 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.

    Measured: Month 12 post-procedure

Secondary outcomes (22)

  1. 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.

    Measured: Month 12 post-procedure

  2. 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.

    Measured: >Month 12 through Month 24 post-procedure

  3. 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.

    Measured: >Month 24 through Month 36 post-procedure

  4. Number of Trial Participants With Amenorrhea

    Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)

    Measured: Month 6 and Month 12 post-procedure

  5. Number of Trial Participants With Amenorrhea

    Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

    Measured: Month 24 post-procedure

  6. Number of Trial Participants With Amenorrhea

    Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

    Measured: Month 36 post-procedure

  7. 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.

    Measured: Baseline, Month 6 and Month 12 post-procedure

  8. 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.

    Measured: Baseline and Month 24 post-procedure

  9. 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.

    Measured: Baseline and Month 36 post-procedure

  10. 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

    Measured: Baseline, Month 6 and Month 12 post-procedure

  11. 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

    Measured: Baseline and Month 24 post-procedure

  12. 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

    Measured: Baseline and Month 36 post-procedure

  13. 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

    Measured: Baseline, Month 6 and Month 12 post-procedure

  14. 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

    Measured: Baseline and Month 24 post-procedure

  15. 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

    Measured: Baseline and Month 36 post-procedure

  16. 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

    Measured: Baseline, Month 6 and Month 12 post-procedure

  17. 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

    Measured: Baseline and Month 24 post-procedure

  18. 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

    Measured: Baseline and Month 36 post-procedure

  19. 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

    Measured: Day of Procedure (during the procedure)

  20. 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

    Measured: Day of Procedure (prior to the procedure)

  21. 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)

    Measured: Pre-Procedure (on day of, prior to procedure), Discharge (post-procedure, prior to discharge) and 24-hours post-procedure

  22. Procedure Details: Recovery Time

    Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge

    Measured: Day of Procedure (post-procedure, prior to discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start28 Feb 2020
  3. Primary completion20 Jul 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04267562
Sponsor's protocol ID
TD18036
Status last verified
Oct 2024
First submitted
10 Feb 2020
Last updated
18 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Minitouch System in people with Menorrhagia and Heavy Menstrual Bleeding, run by MicroCube, LLC at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75) (time frame: Month 12 post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04267562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.

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