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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.

RecruitingNAAges 18 Years - 48 YearsFemaleUniversity Hospital, Ghent
NCT05702281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe. This multicentre, open-label study will take place at the Women's Clinic of Ghent University Hospital in Belgium (International Coordinating Centre) and at the University Hospital AOU Federico II of Naples in Italy. Primary aim: To evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations. Providing no complications develop, participants will remain in the st

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📋 Eligibility rules (as published)
Inclusion Criteria: * Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy * Be willing to come back for the follow-ups * Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion * Sign a written informed consent * Fundus thickness should be 11mm or more Exclusion Criteria: * T and Y shaped uterus * U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation) * Complete septate U2b uterus * Bicorporal U3-U6 uterus * Injectables contraceptive use in the last 6 months * The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out) * Intrauterine fibroids (intra-mural, intracavitary or submucosal) * Cancer or other disease of the uterus * Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject * Blood clotting disorders * Intrauterine polyps * Subjects receiving corticosteroid therapy or immunosuppressive drugs * Morbus Wilson * AIDS * Pregnancy
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What it tests

  • ReLARC
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Where

1 site
University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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