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A Two-Phase Clinical Study of the Minerva AURORA Ablation System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035332
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : October 23, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Minerva Surgical, Inc.

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Due to Benign Causes Device: Aurora Endometrial Ablation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Study Start Date : May 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Aurora Treatment Arm
Endometrial Ablation
Device: Aurora Endometrial Ablation System
Ablation of the endometrial lining of the uterus using the Aurora System




Primary Outcome Measures :
  1. Reduction in Menstrual Blood Loss to Normal Levels at 12-months [ Time Frame: 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 :
  1. Procedure Time [ Time Frame: Day of procedure ]
    Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
  2. Female subject from age 35 to 50 years
  3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
  4. 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

    1. had at least 3 prior months documented failed medical therapy; or
    2. had a contraindication to medical therapy; or
    3. refused medical therapy
  5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
  6. Not pregnant and no desire to conceive at any time
  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

Exclusion Criteria:

  1. Pregnancy or subject with a desire to conceive
  2. Complex endometrial hyperplasia as confirmed by histology
  3. Presence of active endometritis
  4. Active pelvic inflammatory disease
  5. Active sexually transmitted disease (STD)
  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
  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., transmural 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
  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)
  18. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
  19. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
  20. Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035332


Locations
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Hungary
University of Szeged
Szeged, Csongrad, Hungary, 6725
Kenézy Hospital
Debrecen, Hajdú-Bihar, Hungary, 4043
Szt Imre Hospital
Budapest, Hungary, 1115
Sponsors and Collaborators
Minerva Surgical, Inc.
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Responsible Party: Minerva Surgical, Inc.
ClinicalTrials.gov Identifier: NCT02035332    
Other Study ID Numbers: CIP0001
First Posted: January 14, 2014    Key Record Dates
Results First Posted: October 23, 2015
Last Update Posted: October 23, 2015
Last Verified: September 2015
Keywords provided by Minerva Surgical, Inc.:
Excessive Uterine Bleeding
Menorrhagia
Endometrial Ablation
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances