Trial Outcomes & Findings for A Two-Phase Clinical Study of the Minerva AURORA Ablation System (NCT NCT02035332)

NCT ID: NCT02035332

Last Updated: 2015-10-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2015-10-23

Participant Flow

Subjects were enrolled in the clinical trial at 3 investigational sites in Hungary from May 2011 until October 2011.

23 subjects enrolled: 2 subjects excluded based on pre-procedure hysteroscopy findings and did not receive treatment, in 1 subject treatment was attempted but procedure was aborted due to the width of the uterus, the remaining 20 subjects completed study treatment. The protocol ITT population included all subjects in whom treatment was attempted.

Participant milestones

Measure	Aurora Treatment Arm Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Overall Study STARTED	21
Overall Study Treated	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Aurora Treatment Arm Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Overall Study Procedure Aborted due to Uterine Width	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Aurora Treatment Arm n=23 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Age, Continuous	43.9 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Hungary	23 participants n=5 Participants
PBLAC Score (assessment of menstrual blood loss)	419.2 units on a scale STANDARD_DEVIATION 152.2 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)

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.

Outcome measures

Measure	Aurora Treatment Arm n=21 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Reduction in Menstrual Blood Loss to Normal Levels at 12-months	20 participants

SECONDARY outcome

Timeframe: Day of procedure

Population: Subjects completing treatment

Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.

Outcome measures

Measure	Aurora Treatment Arm n=20 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Procedure Time	5.2 Minutes Standard Deviation 2.1

POST_HOC outcome

Timeframe: 12 Months

Population: Protocol Intent-to-treat

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

Outcome measures

Measure	Aurora Treatment Arm n=21 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Subjects With Amenorrhea at 12 Months	11 participants

Adverse Events

Aurora Treatment Arm

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aurora Treatment Arm n=21 participants at risk Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Cardiac disorders Surgery for Heart Valve Replacement	4.8% 1/21 • Number of events 1 • 1 year

Other adverse events

Measure	Aurora Treatment Arm n=21 participants at risk Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Surgical and medical procedures Anesthesia Related	28.6% 6/21 • Number of events 6 • 1 year
Reproductive system and breast disorders Bleeding	28.6% 6/21 • Number of events 6 • 1 year
Reproductive system and breast disorders Pelvic Cramping (non-specific)	42.9% 9/21 • Number of events 9 • 1 year
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Back pain-occasional in middle-back	4.8% 1/21 • Number of events 1 • 1 year
Pregnancy, puerperium and perinatal conditions pregnancy- empty sac	4.8% 1/21 • Number of events 1 • 1 year
Cardiac disorders Chest Pain	4.8% 1/21 • Number of events 1 • 1 year
General disorders Weakness	4.8% 1/21 • Number of events 1 • 1 year

Additional Information

Dr. Eugene Skalnyi, VP Medical Affairs

Minerva Surgical, Inc.

Phone: (1) 650-284-3500

Email: eugenes@minervasurgical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place