Adiana Post-Approval Clinical Study (APACS) (APACS)
19. oktober 2012 opdateret af: Hologic, Inc.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
169
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Elk Grove, California, Forenede Stater, 95758
- Sutter Medical Group
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-
Illinois
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Arlington Heights, Illinois, Forenede Stater, 60004
- WomenCare, P.C.
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-
Missouri
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Columbia, Missouri, Forenede Stater, 65203
- University of Missouri Health Care
-
-
North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Valaoras & Lewis Obstetrics and Gynecology
-
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Ohio
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Columbus, Ohio, Forenede Stater, 43231
- Complete Healthcare For Women
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-
Oregon
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Redmond, Oregon, Forenede Stater, 97756
- The Women's Center of Central Oregon
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Salem, Oregon, Forenede Stater, 97302
- Salem Women's Clinic
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Western Pennsylvania Hospital
-
-
Virginia
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Danville, Virginia, Forenede Stater, 24541
- Ob/Gyn Associates of Danville
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
Tidsramme: 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.
|
At one and two years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety Endpoints
Tidsramme: 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.
|
At one and two years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Edward Evantash, MD, Hologic, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2010
Studieafslutning (Faktiske)
1. april 2012
Datoer for studieregistrering
Først indsendt
5. august 2010
Først indsendt, der opfyldte QC-kriterier
6. august 2010
Først opslået (Skøn)
9. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. oktober 2012
Sidst verificeret
1. oktober 2012
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- S0210001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .