- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267562
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness (EASE Clinical Trial)
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Newburgh, Indiana, United States, 47630
- CMB Research
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Ohio
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Mason, Ohio, United States, 45040
- Amy Brenner, MD & Associates
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Texas
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Austin, Texas, United States, 78705
- Women's Health Texas (Women Partners in Health)
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Austin, Texas, United States, 78758
- AA ObGyn
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Austin, Texas, United States, 78758
- OBGYN North
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Single-Arm, Open-Label Treatment with the Minitouch System
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System
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The investigational treatment (endometrial ablation) will be performed utilizing the Minitouch System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
Time Frame: Month 12 post-procedure
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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
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Number of Trial Participants With Device or Procedure-related Serious Adverse Events
Time Frame: Month 12 post-procedure
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The primary safety endpoint is the incidence of device or procedure-related serious adverse events.
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Month 12 post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal Bleeding
Time Frame: Month 12 post-procedure
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Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
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Month 12 post-procedure
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Number of Trial Participants With Amenorrhea
Time Frame: Month 6 and Month 12 post-procedure
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Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)
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Month 6 and Month 12 post-procedure
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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
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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
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Dysmenorrhea-related Pain Score
Time Frame: Baseline, Month 6 and Month 12 post-procedure
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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.
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Baseline, Month 6 and Month 12 post-procedure
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Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Time Frame: Baseline, Month 6 and Month 12 post-procedure
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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
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Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
Time Frame: Baseline, Month 6 and Month 12 post-procedure
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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
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Menorrhagia Impact Questionnaire (MIQ 4) - Limitations in Social or Leisure Activities
Time Frame: Baseline, Month 6 and Month 12 post-procedure
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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
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Procedure Details: Type of Setting in Which the Procedure Took Place
Time Frame: Day of Procedure (prior to the procedure)
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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
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Day of Procedure (prior to the procedure)
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Procedure Details: Number of Trial Participants in Which a Cervical Dilator Was Used
Time Frame: Day of Procedure (during the procedure)
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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
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Day of Procedure (during the procedure)
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Procedure Details: Recovery Time
Time Frame: Day of Procedure (post-procedure, prior to discharge)
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Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge
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Day of Procedure (post-procedure, prior to discharge)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott G Chudnoff, MD, MSc, Maimonides Medical Center
- Principal Investigator: Amy Brenner, MD, Amy Brenner, MD & Associates, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD18036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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