Trial Outcomes & Findings for Adiana Post-Approval Clinical Study (APACS) (NCT NCT01177670)

NCT ID: NCT01177670

Last Updated: 2012-11-20

Results Overview

The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.

• Recruitment status: TERMINATED
• Target enrollment: 169 participants
• Primary outcome timeframe: At one and two years
• Results posted on: 2012-11-20

Participant Flow

This study was designed to be conducted at 8-10 clinical sites and enroll 1000 subjects.Enrolled subjects were to have baseline data collected at the time of their procedure and then be followed for 2 years with visits occurring at 3 months following the procedure, 6 months following the procedure, 12 and 24 months post relying date.

Participant milestones

Measure	Enrolled All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
Overall Study STARTED	169
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	169

Reasons for withdrawal

Measure	Enrolled All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
Overall Study Study Terminated	115
Overall Study Physician Decision	50
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Adiana Post-Approval Clinical Study (APACS)

Baseline characteristics by cohort

Measure	Enrolled n=169 Participants All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	169 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	35.8 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	169 participants n=5 Participants

PRIMARY outcome

Timeframe: At one and two years

Population: Efficacy results were not tabulated due to the early termination of the study. Only 169 of the planned 1,000 subjects (16.9%) were enrolled therefore the study is defined as incomplete, as fewer than one-third of the intended patients were enrolled.

The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At one and two years

Population: Intent to treat

The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.

Outcome measures

Measure	Enrolled n=169 Participants All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
Safety Endpoints Adverse Event Related to Procedure	79 participants
Safety Endpoints Serious Adverse Event	1 participants
Safety Endpoints Serious and Related Adverse Event	0 participants

Adverse Events

Enrolled

Serious events: 1 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enrolled n=169 participants at risk All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
Infections and infestations Hepatitis C	0.59% 1/169 • Number of events 1

Other adverse events

Measure	Enrolled n=169 participants at risk All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
General disorders Pain or Cramping	33.1% 56/169
Vascular disorders Bleeding	19.5% 33/169
Reproductive system and breast disorders Pregnancy	3.0% 5/169
Gastrointestinal disorders Nausea	2.4% 4/169

Additional Information

Edward Evantash, MD

Hologic, Inc.

Phone: 508-263-8475

Email: edward.evantash@hologic.com

Results disclosure agreements

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

Restriction type: LTE60