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Completed

NCT Number: NCT04267562

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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Heavy Uterine Bleeding Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CMB Research, Newburgh, Indiana, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

Treatment and study plan

Minitouch System

Device

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

Primary outcomes

  1. Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)

    Time frame: Month 12 post-procedure

    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.

  2. Number of Trial Participants With Device or Procedure-related Serious Adverse Events

    Time frame: Month 12 post-procedure

    The primary safety endpoint is the incidence of device or procedure-related serious adverse events.

Secondary outcomes

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

    Time frame: Month 12 post-procedure

    Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

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

    Time frame: >Month 12 through Month 24 post-procedure

    Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

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

    Time frame: >Month 24 through Month 36 post-procedure

    Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

  4. Number of Trial Participants With Amenorrhea

    Time frame: Month 6 and Month 12 post-procedure

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

  5. Number of Trial Participants With Amenorrhea

    Time frame: Month 24 post-procedure

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

  6. Number of Trial Participants With Amenorrhea

    Time frame: Month 36 post-procedure

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

  7. Dysmenorrhea-related Pain Score

    Time frame: Baseline, Month 6 and Month 12 post-procedure

    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.

  8. Dysmenorrhea-related Pain Score

    Time frame: Baseline and Month 24 post-procedure

    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.

  9. Dysmenorrhea-related Pain Score

    Time frame: Baseline and Month 36 post-procedure

    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.

  10. Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home

    Time frame: Baseline, Month 6 and Month 12 post-procedure

    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

  11. Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home

    Time frame: Baseline and Month 24 post-procedure

    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

  12. Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home

    Time frame: Baseline and Month 36 post-procedure

    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

  13. Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity

    Time frame: Baseline, Month 6 and Month 12 post-procedure

    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

  14. Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity

    Time frame: Baseline and Month 24 post-procedure

    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

  15. Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity

    Time frame: Baseline and Month 36 post-procedure

    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

  16. Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities

    Time frame: Baseline, Month 6 and Month 12 post-procedure

    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

  17. Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities

    Time frame: Baseline and Month 24 post-procedure

    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

  18. Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities

    Time frame: Baseline and Month 36 post-procedure

    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

  19. Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used

    Time frame: Day of Procedure (during the procedure)

    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

  20. Procedure Details: Type of Setting in Which the Procedure Took Place

    Time frame: Day of Procedure (prior to the procedure)

    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

  21. Procedure-related Pain Score

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

    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)

  22. Procedure Details: Recovery Time

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

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

Other outcomes

  1. Additonal Measure - Subject Self-Report of Pregnancy

    Time frame: Month 36 post-procedure

    Count of subject self-report of pregnancy at Month 36 to satisfy the post-approval study (PAS) reporting requirements

  2. Additonal Measure - Contraception Status at Month 36

    Time frame: Month 36 post-procedure

    Count of subject contraception menthods reported at Month 36 to satisfy the post-approval study (PAS) reporting requirements; subjects could report more than one method of contraception so numbers may be greater than the total of subjects

  3. Additonal Measure - Gynecologic Adverse Events

    Time frame: Month 24 and Month 36 post-procedure

    Count of number of subjects that reported gynecologic adverse events through Month 24 and Month 36;

Sponsors and collaborators

Lead sponsor

MicroCube, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 13, 2020
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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