Occlusion of the fallopian tubes sterilization with the aid of hysteroscopy
Conditions
Sponsors
AltaScience Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 44 years. Body weight within range of 40-136kg. Patients who are seeking permanent contraception. Patients who have at least one live birth. Patients who are willing to participate in the clinical study and are able to provide written informed consent prior to study participation and agree to comply with all study specified requirements. Willing to undergo a transvaginal and/or transabdominal ultrasound following insertion of the device. Willing to use cover contraception post implantation. Patients with a negative urinary hCG test.
Exclusion criteria
Exclusion criteria: Patients uncertain about their desire to end fertility. Patients in whom only one implant can be placed (including patients with apparent contralateral proximal tubal occlusion and patients with a suspected unicornuate uterus). Patients who are pregnant or suspected pregnant. Patients who have had a delivery or termination of a second trimester pregnancy less than 6 weeks before the AltaSeal® placement procedure. Patients who have previously undergone a tubal ligation. Patients with active or recent upper or lower pelvic infection. Patients in whom both tubal ostia cannot be clearly identified . Patients with a bifid uterus which inhibits implant placement. Patients with a known allergy to any of the materials used in the device. Patients with a known allergy to contrast media. Patients undergoing immunosuppressive therapy are discouraged. Patients who are incapable of giving their own consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: Safety is assessed by measuring major complication rates/serious adverse event rates associated with the use of the AltaSeal® device. Efficacy is assessed by measuring the number of confirmed pregnancies at 1 year among patients told to rely on AltaSeal® for contraception. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: The secondary endpoints of this Pivotal Study are minor complications, reliance rate and patient satisfaction and comfort with placement procedure and device wearing. The overall aim of the AltaSeal® device in this study is to achieve bilateral occlusion of the fallopian tubes in a manner that is tolerable and safe to the patient. The primary safety and efficacy endpoints will be the principal indicators of success. | — |
Countries
Netherlands
Outcome results
None listed