Occlusion of the Fallopian Tubes sterilization with aid of hysteroscopy
Conditions
Sponsors
AltaScience Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged 22 to 44 years. 2) Body weight within range of 40-180kg. 3) Patients who are seeking permanent contraception. 4) Patients who have at least one live birth. 5) Patients who are willing to participate in a clinical study and are able to provide written informed consent prior to study participation and agree to comply with all study specified requirements. 6) Willing to undergo a TV/TA ultrasound both immediately and at 12 weeks following implantation of the device. 7) Willing to use cover contraception for 3 months post implantation. 8) Patients with a negative urinary hCG test.
Exclusion criteria
Exclusion criteria: 1) Patients uncertain about their desire to end fertility. 2) Patients with only one fallopian tube. 3) Patients who are pregnant or suspected pregnant. 4) Patients who have had a delivery or termination of a second trimester pregnancy less than 6 weeks before the AltaSeal® placement procedure. 5) Patients who have previously undergone a tubal ligation or other permanent sterilisation methods e.g. Essure® device. 6) Patients with active or recent upper or lower pelvic infection. 7) Patients in whom both tubal ostia cannot be clearly identified . 8) Patients with a bifid uterus which inhibits implant placement. 9) Patients with a known allergy to any of the materials used in the device. 10) Patients with a known allergy to contrast media. 11) Patients undergoing immunosuppressive therapy. 12) Patients who, in the investigator*s opinion, are not suitable candidates for the device placement procedure due to inability to comply with the protocol requirements. 13) Patients who are incapable of giving their own consent. 14) Patients with a cervical or uterine malignancy or un-investigated irregular vaginal bleeding. 15) Patients who are unsuitable for general/local anaesthetic or the sedation to be used during the procedure. 16) Patients who have a history of severe cramping or abdominal/pelvic pain. *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: Efficacy: * Pregnancy rate at 12 months. * Reliance rate Safety: * Percentage of adverse events (minor & major) following the device placement procedure * Percentage of adverse events (minor & major) following device wearing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Efficacy: * Successful bilateral placement rate * Patient satisfaction with device placement procedure and wearing * Data for the development of the clinical patient profile for appropriate use of the AltaSeal device | — |
Countries
Netherlands
Outcome results
None listed