Trial Outcomes & Findings for A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System (NCT NCT02029911)

NCT ID: NCT02029911

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

Target enrollment

63 participants

Primary outcome timeframe

12 Months

Results posted on

2015-11-05

Participant Flow

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

63 subjects enrolled: 3 subjects excluded based on pre-procedure hysteroscopy screening and did not receive treatment. The remaining 60 subjects completed the study treatment. The protocol ITT population included all subjects in whom treatment was attempted (the experimental device was attempted to be placed).

Participant milestones

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	60
Overall Study Treated	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aurora Treatment Arm n=60 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Age, Continuous	42.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	60 participants n=5 Participants
PBLAC Score (assessment of menstrual blood loss)	503.0 units on a scale STANDARD_DEVIATION 412.3 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Protocol Intent-to-treat populations (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

Outcome measures
Measure	Aurora Treatment Arm n=60 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	58 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

Outcome measures
Measure	Aurora Treatment Arm n=60 Participants Endometrial Ablation Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System
Procedure Time	3.8 Minutes Standard Deviation 1.3

POST_HOC outcome

Timeframe: 12 Months

Population: Protocol Intent-to-treat

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

Outcome measures

Outcome measures
Measure	Aurora Treatment Arm n=60 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	41 participants

Adverse Events

Aurora Treatment Arm

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Aurora Treatment Arm n=60 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	20.0% 12/60 • Number of events 19 • 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 Infection	1.7% 1/60 • 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 Bleeding	1.7% 1/60 • 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)	78.3% 47/60 • Number of events 57 • 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 Pain	5.0% 3/60 • Number of events 3 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
Gastrointestinal disorders Nausea-more than 24 hrs post-treatment	3.3% 2/60 • 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.
Reproductive system and breast disorders Vaginal Discharge	1.7% 1/60 • 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.
Infections and infestations Urinary Tract Infection	6.7% 4/60 • Number of events 4 • 1 year All Adverse Events observed during the clinical study, regardless of relationship to the study device or procedure are reported below.
General disorders Fever more than 24 hrs post-treatment	3.3% 2/60 • 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.
Reproductive system and breast disorders Vulvitis	1.7% 1/60 • 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.
Reproductive system and breast disorders Unpleasant Vaginal Odor	5.0% 3/60 • Number of events 3 • 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 Pruritus Vulvae	1.7% 1/60 • 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 Burning	1.7% 1/60 • 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 Constipaion	3.3% 2/60 • 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.
Injury, poisoning and procedural complications Superficial Thrombosis	1.7% 1/60 • 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 Vagal Reaction	1.7% 1/60 • 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.
Psychiatric disorders Depression	1.7% 1/60 • 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 Dizziness	1.7% 1/60 • 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.
Infections and infestations Annulus Rectal Condyloma	1.7% 1/60 • 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 Abnormal Pap test- CINII	1.7% 1/60 • 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 Dental Ulcer	1.7% 1/60 • 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.
Injury, poisoning and procedural complications ecchymosis	1.7% 1/60 • 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 Diarrhea	1.7% 1/60 • 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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place