A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Primary Purpose
Menorrhagia Due to Benign Causes
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Aurora Endometrial Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Menorrhagia Due to Benign Causes focused on measuring Excessive Uterine Bleeding, Menorrhagia, Endometrial Ablation
Eligibility Criteria
Inclusion Criteria:
- Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
- Female subject from age 35 to 50 years
- Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
A minimum PBLAC score of >150 for 3 months prior to study enrollment; OR, A minimum PBLAC score >150 for one month for women who either
- had at least 3 prior months documented failed medical therapy; or
- had a contraindication to medical therapy; or
- refused medical therapy
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
- Not pregnant and no desire to conceive at any time
- Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
- Subject who is literate or demonstrates an understanding on how to use menstrual diaries
Exclusion Criteria:
- Pregnancy or subject with a desire to conceive
- Complex endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD)
- Presence of bacteremia, sepsis, or other active systemic infection
- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Known/suspected gynecological malignancy within the past 5 years
- Known clotting defects or bleeding disorders
- Untreated/unevaluated cervical dysplasia
- Known/suspected abdominal/pelvic cancer
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
- Previous endometrial ablation procedure
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use
- Currently on anticoagulants
Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:
- Septate or bicornuate uterus or other congenital malformation of the uterine cavity
- Pedunculated or submucosal myomas distorting the uterine cavity
- Polyps likely to be the cause of the subject's menorrhagia
- Intramural or subserosal myomas that distort the uterine cavity
- Presence of an intrauterine device (IUD)
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Sites / Locations
- University of Szeged
- Kenézy Hospital
- Szt Imre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aurora Treatment Arm
Arm Description
Endometrial Ablation
Outcomes
Primary Outcome Measures
Reduction in Menstrual Blood Loss to Normal Levels at 12-months
Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.
Secondary Outcome Measures
Procedure Time
Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.
Full Information
NCT ID
NCT02035332
First Posted
January 10, 2014
Last Updated
September 23, 2015
Sponsor
Minerva Surgical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02035332
Brief Title
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Official Title
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minerva Surgical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia Due to Benign Causes
Keywords
Excessive Uterine Bleeding, Menorrhagia, Endometrial Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aurora Treatment Arm
Arm Type
Experimental
Arm Description
Endometrial Ablation
Intervention Type
Device
Intervention Name(s)
Aurora Endometrial Ablation System
Intervention Description
Ablation of the endometrial lining of the uterus using the Aurora System
Primary Outcome Measure Information:
Title
Reduction in Menstrual Blood Loss to Normal Levels at 12-months
Description
Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Procedure Time
Description
Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.
Time Frame
Day of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
Female subject from age 35 to 50 years
Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
A minimum PBLAC score of >150 for 3 months prior to study enrollment; OR, A minimum PBLAC score >150 for one month for women who either
had at least 3 prior months documented failed medical therapy; or
had a contraindication to medical therapy; or
refused medical therapy
Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Not pregnant and no desire to conceive at any time
Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
Subject who is literate or demonstrates an understanding on how to use menstrual diaries
Exclusion Criteria:
Pregnancy or subject with a desire to conceive
Complex endometrial hyperplasia as confirmed by histology
Presence of active endometritis
Active pelvic inflammatory disease
Active sexually transmitted disease (STD)
Presence of bacteremia, sepsis, or other active systemic infection
Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
Known/suspected gynecological malignancy within the past 5 years
Known clotting defects or bleeding disorders
Untreated/unevaluated cervical dysplasia
Known/suspected abdominal/pelvic cancer
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
Previous endometrial ablation procedure
Currently on medications that could thin the myometrial muscle, such as long-term steroid use
Currently on anticoagulants
Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:
Septate or bicornuate uterus or other congenital malformation of the uterine cavity
Pedunculated or submucosal myomas distorting the uterine cavity
Polyps likely to be the cause of the subject's menorrhagia
Intramural or subserosal myomas that distort the uterine cavity
Presence of an intrauterine device (IUD)
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Facility Information:
Facility Name
University of Szeged
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Kenézy Hospital
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Szt Imre Hospital
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
12. IPD Sharing Statement
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A Two-Phase Clinical Study of the Minerva AURORA Ablation System
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