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Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Overview

Información sobre este estudio

This clinical trial is designed to evaluate the safety and effectiveness of the Essure System for Permanent Birth Control (Model ESS505) in preventing pregnancy. The Essure ESS505 is designed to provide immediate permanent contraception. Bayer HealthCare LLC, the study sponsor has modified the design of the commercially available Essure ESS305 into an investigational device, Essure ESS505. The primary design modification for the ESS505 is the addition of a hydrogel component (plug) attached to the distal end of the Essure insert. The hydrogel plug absorbs intrauterine fluids soon after placement, causing the hydrogel to swell, conform to the fallopian tube, and occlude the fallopian tube within one hour. Immediately after the placement procedure, a transvaginal ultrasound (TVU) will be performed to confirm satisfactory location of the insert. In the event that the TVU does not confirm satisfactory placement, a hysterosalpingogram (HSG) will be required to further evaluate the insert location and tubal occlusion. Subjects enrolled in this study will be instructed to rely solely on the ESS505 for contraception after a satisfactory confirmation test is completed.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Female, 21 to 44 years of age, inclusive.
  • Body weight within range of 90-300 lbs (40 - 136 kg).
  • Sexually active (minimum of 4 coital acts per cycle).
  • Willing to accept the risk of pregnancy while relying solely on the inserts for contraception.
  • Medical history indicates bilateral viable and patent fallopian tubes.
  • Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods.

Exclusion Criteria:

  • Post-menopausal woman.
  • Suspected or confirmed pregnancy.
  • Post-partum or pregnancy termination ≤ 6 weeks of scheduled insert placement.
  • Past fallopian tube sterilization procedure and/or total or partial salpingectomies.
  • Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy.
  • Currently taking corticosteroids.
  • Known allergy to all contrast media available for use in hysterosalpingogram.
  • Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure).
  • 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Hopkins, M.D.

Cerrado para la inscripción

Contact information:

Maureen Lemens C.C.R.C.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publicaciones

Publications are currently not available

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CLS-20485598

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