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Essure (Model ESS310) Placement Rate Study

6. april 2021 opdateret af: Bayer

A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System

To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85304
      • Phoenix, Arizona, Forenede Stater, 85015
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80923
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30909
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46825
      • Newburgh, Indiana, Forenede Stater, 47630
    • Michigan
      • Grand Blanc, Michigan, Forenede Stater, 48439
      • Saginaw, Michigan, Forenede Stater, 48604
      • Southfield, Michigan, Forenede Stater, 48034
        • Wayne State University Physicians Group
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic - Rochester
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
    • Ohio
      • Dayton, Ohio, Forenede Stater, 45409-2793
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forenede Stater, 37205
        • Tennessee Women's Care, PC
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
      • Houston, Texas, Forenede Stater, 77074

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

21 år til 44 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Females aged range 21 to 44 years
  • Subjects seeking permanent contraception
  • Subjects with body weight within range of 90-300 pounds (40 - 136 kilograms)
  • Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
  • Subjects are able and willing to comply with the protocol required follow-up visits
  • Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
  • Subjects provide written informed consent prior to enrolment
  • Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
  • Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies

Exclusion Criteria:

  • Subjects suspected of being or confirmed pregnant
  • Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
  • Subjects who have known proximal tubal occlusion in either fallopian tube
  • Subjects who have undergone fallopian tube sterilization procedure
  • Subjects who have had total or partial salpingectomies
  • Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
  • Subjects diagnosed with unicornuate uterus
  • Subjects diagnosed with active or currently being treated upper or lower pelvic infection
  • Subjects with gynecologic malignancy
  • Subjects who are currently taking corticosteroids
  • Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
  • Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
  • Subjects with any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
  • Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor's staff)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ESS310
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
Enhed: ESS310 (BAY1454032)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Tidsramme: Day 1
Day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
Tidsramme: Day 1
Day 1
Evaluation of investigator questionnaire regarding ESS310 design and usability
Tidsramme: Day 1
Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
Day 1
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
Tidsramme: Day 1
Day 1
Hysteroscopy time to perform the procedure
Tidsramme: Day 1
Day 1
Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
Tidsramme: 1 week
1 week
Number of participants with Adverse procedure-related events as a measure of safety and tolerability
Tidsramme: Day 1, 1 week
Day 1, 1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

17. marts 2014

Primær færdiggørelse (Faktiske)

2. oktober 2014

Studieafslutning (Faktiske)

26. november 2014

Datoer for studieregistrering

Først indsendt

14. februar 2014

Først indsendt, der opfyldte QC-kriterier

14. februar 2014

Først opslået (Skøn)

17. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 17069

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 .

Kliniske forsøg med ESS310 (BAY1454032)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Switzerland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner