Menorrhagia Due to Benign CausesNCT02023801
A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
A study testing Aurora Endometrial Ablation System in people with Menorrhagia Due to Benign Causes, run by Minerva Surgical, Inc. at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Menorrhagia Due to Benign Causes
- What is being tested?
- Aurora Endometrial Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Documented history of menorrhagia secondary to dysfunctional uterine bleeding (DUB).
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Menorrhagia Due to Benign Causes
- Being tested
- Aurora Endometrial Ablation System
- Keywords
- Menorrhagia, Dysfunctional Uterine Bleeding, Endometrial Ablation
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurora Endometrial Ablation SystemDevice
Ablation of the endometrial lining of the uterus using the Aurora System
| Study group | Role | What they receive |
|---|---|---|
| Aurora Treatment Arm | Experimental | Endometrial Ablation Receives: Device: Aurora Endometrial Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (1)
Procedure Time
Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal
Measured: < 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Menorrhagia Due to Benign CausesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023801
- Sponsor's protocol ID
- CIP0004
- Status last verified
- Oct 2015
- First submitted
- 24 Dec 2013
- Last updated
- 5 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
- ClinicalTrials.gov ID
- NCT02023801
- Acronym / sponsor ID
- CIP0004
- Conditions
- Menorrhagia Due to Benign Causes
- Keywords
- Menorrhagia, Dysfunctional Uterine Bleeding, Endometrial Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Minerva Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 5 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aurora Treatment Arm | Experimental | Device: Aurora Endometrial Ablation SystemEndometrial Ablation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurora Endometrial Ablation SystemAblation of the endometrial lining of the uterus using the Aurora System | Device | Aurora Treatment Arm |
Primary outcome
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.
1 secondary outcome
Procedure Time
Time frame: < 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Menorrhagia Due to Benign Causes
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Menorrhagia Due to Benign Causes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aurora Endometrial Ablation System in people with Menorrhagia Due to Benign Causes, run by Minerva Surgical, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.