Women ContraceptionAPACSNCT01177670
Adiana Post-Approval Clinical Study (APACS)
An observational study of Women Contraception, run by Hologic, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Contraception
- How many people
- 169 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2010to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
WomenCare, P.C.
Arlington Heights, Illinois, 60004
University of Missouri Health Care
Columbia, Missouri, 65203
Complete Healthcare for Women
Columbus, Ohio, 43231
Ob/Gyn Associates of Danville
Danville, Virginia, 24541
Sutter Medical Group
Elk Grove, California, 95758
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
The Women's Center of Central Oregon
Redmond, Oregon, 97756
Salem Women's Clinic
Salem, Oregon, 97302
Valaoras & Lewis Obstetrics and Gynecology
Winston-Salem, North Carolina, 27103
About this study
Official title: Adiana Post-Approval Clinical Study
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.
Read the 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.
- Conditions
- Women Contraception
- Keywords
- Adiana Permanent Contraception System, women seeking permanent sterilization.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At one and two years
Secondary outcomes (1)
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.
Measured: At one and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startAug 2010
- Study completionApr 2012
Why it stopped: Hologic made business decision to no longer sell or manufacture Adiana device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Women ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Evantash, MD, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177670
- Sponsor's protocol ID
- S0210001
- Acronym
- APACS
- Status last verified
- Oct 2012
- First submitted
- 5 Aug 2010
- Last updated
- 20 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiana Post-Approval Clinical Study
- ClinicalTrials.gov ID
- NCT01177670
- Acronym / sponsor ID
- APACS / S0210001
- Conditions
- Women Contraception
- Keywords
- Adiana Permanent Contraception System, women seeking permanent sterilization.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Hologic made business decision to no longer sell or manufacture Adiana device.
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
Time frame: 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.
1 secondary outcome
Safety Endpoints
Time frame: At one and two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Evantash, MD study director
Hologic, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women Contraception, run by Hologic, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception. (time frame: At one and two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.