A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Primary Purpose
Menorrhagia Due to Benign Causes
Status
Completed
Phase
Not Applicable
Locations
Canada
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 Menorrhagia, Excessive uterine bleeding, Endometrial Ablation
Eligibility Criteria
Inclusion Criteria:
- Refractory menorrhagia with no definable organic cause
- Female subject from age 25 to 50 years
- Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
One of the following criteria:
A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB).
B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a minimum PBLAC score of ≥150 for 1 month prior to study enrollment.
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
- Not pregnant and no desire to be pregnant in the future
- 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 for PBLAC analysis.
- Subject who is literate or demonstrates an understanding on how to use menstrual diaries.
Exclusion Criteria:
- Pregnancy or subject with a desire to conceive
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
- 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 (except CIN I)
- Known/suspected abdominal/pelvic cancer
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
- Previous endometrial ablation procedure
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- 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) which the patient is unwilling to have removed at the time of the operative visit
- Presence of an implantable contraceptive device (e.g. Essure or Adiana).
- Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device).
- Subject who is within 6-weeks post partum.
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
- Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.
Sites / Locations
- Hôpital du Sacré-Coeur de Montréal
- Hôpital Lasalle
- La Cite Medicale
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.
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
NCT02029911
First Posted
January 6, 2014
Last Updated
October 6, 2015
Sponsor
Minerva Surgical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02029911
Brief Title
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Official Title
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 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
This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an objective standard. Safety will be evaluated by determining the number and percentage of subjects who experience one or more of serious adverse events.
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
Menorrhagia, Excessive uterine bleeding, 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
63 (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.
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
< 1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refractory menorrhagia with no definable organic cause
Female subject from age 25 to 50 years
Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
One of the following criteria:
A. Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB).
B. If a pictorial blood loss assessment chart (PBLAC) scoring systems is used; a minimum PBLAC score of ≥150 for 1 month prior to study enrollment.
Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Not pregnant and no desire to be pregnant in the future
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 for PBLAC analysis.
Subject who is literate or demonstrates an understanding on how to use menstrual diaries.
Exclusion Criteria:
Pregnancy or subject with a desire to conceive
Endometrial hyperplasia as confirmed by histology
Presence of active endometritis
Active pelvic inflammatory disease
Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
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 (except CIN I)
Known/suspected abdominal/pelvic cancer
Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
Previous endometrial ablation procedure
Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
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) which the patient is unwilling to have removed at the time of the operative visit
Presence of an implantable contraceptive device (e.g. Essure or Adiana).
Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device).
Subject who is within 6-weeks post partum.
Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.
Facility Information:
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hôpital Lasalle
City
Ville Lassalle
State/Province
Quebec
ZIP/Postal Code
H8P 1C1
Country
Canada
Facility Name
La Cite Medicale
City
Quebec
ZIP/Postal Code
G1W 2J5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
We'll reach out to this number within 24 hrs