An observational study in Women Contraception, sponsored by Hologic, Inc.. Terminated at 9 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-20.
Sponsored by Hologic, Inc. · Observational
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.
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.
Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.
Exclusion Criteria:
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
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
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.
| Milestone | Enrolled |
|---|---|
| Started | 169 |
| Completed | 0 |
| Not completed | 169 |
| Withdrew: Study terminated | 115 |
| Withdrew: Physician decision | 50 |
| Withdrew: Withdrawal by subject | 4 |
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.
No measurements were reported for this outcome.
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.
| participants | Enrolled |
|---|---|
| Adverse Event Related to Procedure | 79 |
| Serious Adverse Event | 1 |
| Serious and Related Adverse Event | 0 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled | — | 1/169 (0.6%) | 80/169 (47.3%) |
| Event | Enrolled |
|---|---|
| Hepatitis CInfections and infestations | 1/169 |
| Event | Enrolled |
|---|---|
| Pain or CrampingGeneral disorders | 56/169 |
| BleedingVascular disorders | 33/169 |
| PregnancyReproductive system and breast disorders | 5/169 |
| NauseaGastrointestinal disorders | 4/169 |
| Age, Categorical(Participants) | Enrolled |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 169 |
| >=65 years | 0 |
| Age Continuous(years) | Enrolled |
|---|---|
| Mean | 35.8 ± 5.4 |
| Sex: Female, Male(Participants) | Enrolled |
|---|---|
| Female | 169 |
| Male | 0 |
| Region of Enrollment(participants) | Enrolled |
|---|---|
| United States | 169 |
This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Hologic, Inc.