Trial Outcomes & Findings for Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation (NCT NCT01569763)

Last Updated: 2018-04-18

Results Overview

Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.

Recruitment status

COMPLETED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

12 months

Results posted on

2018-04-18

Participant Flow

Subjects were enrolled in the clinical trial at 13 Investigational Sites in the U.S., Canada, and Mexico between March 2012 until November 2013.

A total of 153 subjects were enrolled and randomized 2:1 to the Minerva (Aurora) Test Group (n=102) or the Rollerball Control Group (n=51). As part of the randomization process, subjects were stratified by age, though there was no attempt to enroll an equal number into the \< 40 and \> 40 age groups. All 153 subjects were successfully treated.

Participant milestones

Participant milestones
Measure	Aurora Endometrial Ablation Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Overall Study STARTED	102	51
Overall Study Treated	102	51
Overall Study COMPLETED	99	44
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Aurora Endometrial Ablation Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Overall Study Lack of Efficacy	2	7
Overall Study Adverse Event	1	0

Baseline Characteristics

Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aurora Endometrial Ablation n=102 Participants Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 Participants Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation	Total n=153 Participants Total of all reporting groups
Age, Continuous	42.6 years STANDARD_DEVIATION 4.2 • n=5 Participants	42.5 years STANDARD_DEVIATION 4.7 • n=7 Participants	42.5 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	51 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	54 participants n=5 Participants	26 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	12 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Mexico	28 participants n=5 Participants	13 participants n=7 Participants	41 participants n=5 Participants
Alkaline Hematin Value at Baseline	310.2 Menstrual Blood Loss (ml) STANDARD_DEVIATION 169.0 • n=5 Participants	301.8 Menstrual Blood Loss (ml) STANDARD_DEVIATION 176.1 • n=7 Participants	307.4 Menstrual Blood Loss (ml) STANDARD_DEVIATION 170.9 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All Randomized subjects in whom treatment was attempted

Outcome measures

Outcome measures
Measure	Aurora Endometrial Ablation n=102 Participants Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 Participants Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months	95 participants	41 participants

SECONDARY outcome

Timeframe: < 1 hour

Population: Subjects completing treatment

Procedure time is defined as the time from device insertion to time of device removal.

Outcome measures

Outcome measures
Measure	Aurora Endometrial Ablation n=102 Participants Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 Participants Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Procedure Time	3.1 Minutes Standard Deviation 0.5	17.2 Minutes Standard Deviation 6.7

POST_HOC outcome

Timeframe: 12 Months

Population: Randomized subjects

Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding

Outcome measures

Outcome measures
Measure	Aurora Endometrial Ablation n=102 Participants Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 Participants Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Subjects With Amenorrhea at 12 Months	73 participants	25 participants

Adverse Events

Aurora Endometrial Ablation

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Hysteroscopic Rollerball Resection/Ablation

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aurora Endometrial Ablation n=102 participants at risk Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 participants at risk Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Reproductive system and breast disorders Bleeding	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Endometritis	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Pelvic Inflammatory Disease (PID)	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Surgical and medical procedures Anesthesia Related	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Endocrine disorders Thyroid Nodule	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloma	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Metabolism and nutrition disorders Hyponatremia	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Continued Heavy Menstrual Bleeding	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.

Other adverse events

Other adverse events
Measure	Aurora Endometrial Ablation n=102 participants at risk Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system	Hysteroscopic Rollerball Resection/Ablation n=51 participants at risk Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
Skin and subcutaneous tissue disorders Skin Rash and/or Itching or Burning Sensation	2.0% 2/102 • Number of events 2 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Bleeding or spotting	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Gastrointestinal disorders Nausea and/or Vomiting	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Musculoskeletal and connective tissue disorders Backache	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Surgical and medical procedures Fever	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Gastrointestinal disorders Abdominal Pain and/or Bloating	2.9% 3/102 • Number of events 3 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	3.9% 2/51 • Number of events 2 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Pelvic Pain	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Vaginal discharge, unpleasant smell, burning, abnormal sensation	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
General disorders Weaknes, Fatigue, Sleepiness, Lack of concentration, Dizziness	2.0% 2/102 • Number of events 2 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Gastrointestinal disorders Constipation	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Endometritis or Endomyometritis	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	3.9% 2/51 • Number of events 2 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Pelvic Inflammatory Disease (PID)	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Hematometra	0.98% 1/102 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	0.00% 0/51 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/102 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.	2.0% 1/51 • Number of events 1 • 1 year All Serious Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below. All non-Serious Adverse Events considered possibly, probably or highly probably related to the device or procedure are reported below.

Additional Information

Dr. Eugene Skalnyi, VP Medical Affairs

Minerva Surgical, Inc.

Phone: (1) 650-284-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator has the right to publish their research for non-profit and academic purposes, provided the 1st publication of results shall be in conjunction with results from all centers in this Study. If Investigator desires to publish/present data obtained by Investigator, following completion of the Study at all sites, Investigator may do so, provided a copy of proposed publication/presentation is received by Company for review/comment at least 15 days in advance of submission for publication.
Publication restrictions are in place

Restriction type: OTHER