Trial Outcomes & Findings for A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System (NCT NCT02023801)

NCT ID: NCT02023801

Last Updated: 2015-11-05

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2015-11-05

Participant Flow

Subjects were enrolled in the clinical trial at 1 Investigational Site in Mexico. All subjects were enrolled during September 2011.

24 subjects enrolled: all subjects met the study criteria including hysteroscopic screening prior to the procedure. All 24 subjects completed the treatment. The protocol ITT (Intent-To-Treat) population included all subjects in whom treatment was attempted (i.e., all subjects in whom the experimental device was attempted to be placed).

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	24
Overall Study Treated	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Aurora Treatment Arm n=24 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Age, Continuous	38.5 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Mexico	24 participants n=5 Participants
PBLAC Score (assessment of menstrual blood loss)	438.8 units on a scale STANDARD_DEVIATION 263.6 • 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.

Outcome measures

Measure	Aurora Treatment Arm n=24 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	23 participants

SECONDARY outcome

Timeframe: < 1 hour

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=24 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Procedure Time	3.0 Minutes Standard Deviation 0.5

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=24 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	21 participants

Adverse Events

Aurora Treatment Arm

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aurora Treatment Arm n=24 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	25.0% 6/24 • Number of events 11 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Endometritis	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Pelvic Cramping (non-specific)	62.5% 15/24 • Number of events 15 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Pelvic Cramping (dyspareunia)	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Vaginal Discharge	54.2% 13/24 • Number of events 13 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Infections and infestations Urinary Tract Infection	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Pelvic Inflammatory Disease (PID)	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Gastrointestinal disorders Abdominal Bloating	37.5% 9/24 • Number of events 9 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Psychiatric disorders Anxiety/Mood Swings	4.2% 1/24 • Number of events 2 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Gastrointestinal disorders Constipation	8.3% 2/24 • Number of events 2 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
General disorders Flu	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
General disorders Sensation of Weight Gain	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
General disorders Fatigue	8.3% 2/24 • Number of events 2 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
General disorders Hands and Feet Swelling	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Nervous system disorders Headache	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Spotting	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Reproductive system and breast disorders Paresthesia of the Vulva	4.2% 1/24 • Number of events 1 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.

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