Women Contraception
Conditions
Keywords
Adiana Permanent Contraception System, women seeking permanent sterilization.
Brief summary
The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on the efficacy and safety of the Adiana Permanent Contraception System in the post market setting. Specifically, data will be collected that is relevant to the evaluation of the safety and efficacy of the Adiana System for women who desire permanent birth control by occlusion of the fallopian tubes. This study is an observational study that is not intended to test specific hypotheses.
Detailed description
Adiana Post-Approval Clinical Study is a prospective, single armed, multi-center, observational study that is designed to provide additional efficacy and safety data regarding the FDA-approved Adiana Permanent Contraception System. This study will be conducted at 8-10 clinical sites and enroll 1000 subjects. Enrolled subjects will have baseline data collected at the time of their Adiana procedure and will then be followed for a period of 2 years with visits occurring at 3 months following the Adiana procedure, 6 months following Adiana procedure (as applicable), 12 and 24 months post relying date.
Interventions
None listed
Sponsors
Hologic, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who are seeking permanent sterilization * Women 18-45 years old * Subjects who are at risk of becoming pregnant * Subjects willing to use alternative contraception for at least three (3) months following device placement and bilateral tubal occlusion is confirmed by HSG * Subjects who are able to provide informed consent
Exclusion criteria
* Subjects who are uncertain about their desire to end fertility * Clinical evidence of an active pelvic infection or history of a recent pelvic infection * Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (i.e., large submucous fibroids, uterine adhesions, apparent uni or bilateral proximal tubal occlusion, suspected unicornuate uterus, etc.) * Is pregnant (as evidenced by pregnancy test result) or suspects pregnancy * Is currently less than three (3) months since her last pregnancy * Has previously undergone a tubal ligation * Is currently taking immunosuppressive medication (e.g., steroids) * Has a known allergy to contrast media * Has external pacemaker or internal cardioverter defibrillator * Subject is unable to follow the protocol and return for follow up visits * In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception. | At one and two years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoints | At one and two years | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted. | 169 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 50 |
| Overall Study | Study Terminated | 115 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Enrolled |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants |
| Age Continuous | 35.8 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 169 participants |
| Sex: Female, Male Female | 169 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 80 / 169 |
| serious Total, serious adverse events | 1 / 169 |
Outcome results
Primary
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
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.
Time frame: 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.
Secondary
Safety Endpoints
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.
Time frame: At one and two years
Population: Intent to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled | Safety Endpoints | Adverse Event Related to Procedure | 79 participants |
| Enrolled | Safety Endpoints | Serious Adverse Event | 1 participants |
| Enrolled | Safety Endpoints | Serious and Related Adverse Event | 0 participants |