Advanced Pivotal Study for Safety & Efficacy of AltaSeal® a Hysteroscopically Placed Mechanical Occlusion Implant for Hysteroscopic Sterilisatio

Phase 3

Completed

• Conditions: Occlusion of the Fallopian Tubes; sterilization with aid of hysteroscopy; 10029903

• Registration Number: NL-OMON49253
• Lead Sponsor: AltaScience Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

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

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.
*

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints:<br /><br><br /><br>Efficacy:<br /><br><br /><br>* Pregnancy rate at 12 months.<br /><br>* Reliance rate<br /><br><br /><br>Safety:<br /><br>* Percentage of adverse events (minor & major) following the device placement<br /><br>procedure<br /><br>* Percentage of adverse events (minor & major) following device wearing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br><br /><br>Efficacy:<br /><br><br /><br>* Successful bilateral placement rate<br /><br>* Patient satisfaction with device placement procedure and wearing<br /><br>* Data for the development of the clinical patient profile for appropriate use<br /><br>of the AltaSeal device</p><br>