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A 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
Mexico
Study Type
Interventional
Intervention
Aurora Endometrial Ablation System
Sponsored by
Minerva Surgical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia Due to Benign Causes focused on measuring Menorrhagia, Dysfunctional Uterine Bleeding, Endometrial Ablation

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Refractory menorrhagia with no definable organic cause
  2. Female subject from age 25 to 50 years
  3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
  4. 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 3 months prior to study enrollment; OR, A minimum PBLAC score ≥150 for one month for women who either i. had at least 3 prior months documented failed medical therapy; or ii. had a contraindication to medical therapy; or iii. refused medical therapy

  5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
  6. Not pregnant and no desire to be pregnant in the future
  7. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
  8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
  9. Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
  10. Subject who is literate or demonstrates an understanding on how to use menstrual diaries or how to collect and provide used sanitary products

Exclusion Criteria:

  1. Pregnancy or subject with a desire to conceive
  2. Endometrial hyperplasia as confirmed by histology
  3. Presence of active endometritis
  4. Active pelvic inflammatory disease
  5. 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.
  6. Presence of bacteremia, sepsis, or other active systemic infection
  7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
  8. Known/suspected gynecological malignancy within the past 5 years
  9. Known clotting defects or bleeding disorders
  10. Untreated/unevaluated cervical dysplasia (except CIN I)
  11. Known/suspected abdominal/pelvic cancer
  12. Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
  13. Previous endometrial ablation procedure
  14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
  15. Currently on anticoagulants
  16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:

    1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity
    2. Pedunculated or submucosal myomas distorting the uterine cavity
    3. Polyps likely to be the cause of the subject's menorrhagia
    4. Intramural or subserosal myomas that distort the uterine cavity
  17. Presence of an intrauterine device (IUD) which the patient is unwilling to have removed at the time of the operative visit
  18. Presence of an implantable contraceptive device (e.g. Essure or Adiana).
  19. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation (including a Mirena device).
  20. Subject who is within 6-weeks post partum.
  21. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
  22. Any subject who is currently participating or considers future participation in any other research of an investigational drug or device.

Sites / Locations

  • Hospital Universitario, UANL

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

First Posted
December 24, 2013
Last Updated
October 6, 2015
Sponsor
Minerva Surgical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02023801
Brief Title
A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Official Title
A 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
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
May 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 clinical study without a formal hypothesis. The primary objective of the study is to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete or no longer wish to retain fertility.

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, Dysfunctional 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
24 (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 3 months prior to study enrollment; OR, A minimum PBLAC score ≥150 for one month for women who either i. had at least 3 prior months documented failed medical therapy; or ii. had a contraindication to medical therapy; or iii. refused medical therapy 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 Subject who is literate or demonstrates an understanding on how to use menstrual diaries or how to collect and provide used sanitary products 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
Hospital Universitario, UANL
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

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