Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GY… (NCT05702281) | Clinical Trial Compass
RecruitingNot Applicable
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.
Belgium120 participantsStarted 2022-05-01
Plain-language summary
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 study for 3 years. 120 women will be enrolled.
Who can participate
Age range
18 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.