Safety and Effectiveness of ReLARC Device Inserted by Hysteroscopy for Contraception with 3-Year Follow-Up

What this Trial Is About

This research evaluates the safety of the ReLARC inserter, a device designed for hysteroscopic insertion of the GyneFix intrauterine copper contraceptive. The study focuses on successful placement and proper positioning of the device during follow-up. The trial is open-label, multicenter, and involves healthy women aged 18 to 48 years, with an enrollment of 120 participants. ReLARC is inserted using a hysteroscope that allows direct visualization of the uterus during the procedure, enhancing safety. Two versions, ReLARC 3 and ReLARC 10, are used with specific equipment including the KARL STORZ HOPKINS telescope and an irrigation pump. The insertion procedure is followed by monitoring device positioning and participant wellbeing over a three-year period. Participants will attend scheduled follow-ups to assess device position, ease of insertion and removal, pain levels during procedures, and patient satisfaction. Measurements of uterine cavity diameter and tracking of expulsion and removal rates will also be conducted. The study monitors safety and effectiveness of device placement throughout the three years, with some outcomes observed up to seven years.

Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device with a Follow-up of 3 Years.