Actively Recruiting
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.
Led by University Hospital, Ghent · Updated on 2025-01-27
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Generally healthy women aged 18 to 48 years
- No contraindication for hysteroscopy
- Willing to attend follow-up visits
- Willing to avoid intercourse for the first two weeks after insertion
- Willing to avoid tampons and menstrual cups for two months after insertion
- Signed informed consent
- Uterine fundus thickness of 11 mm or more
You will not qualify if you...
- T or Y shaped uterus
- U1 dysmorphic uterus
- Complete septate U2b uterus
- Bicorporal U3-U6 uterus
- Use of injectable contraceptives in the last 6 months
- Presence of uterine infection, cervicitis, or vaginitis
- Intrauterine fibroids (intramural, intracavitary, or submucosal)
- Cancer or other uterine diseases
- Any malignancy or history of melanoma or gynecological cancer
- Blood clotting disorders
- Intrauterine polyps
- Use of corticosteroids or immunosuppressive drugs
- Morbus Wilson
- AIDS
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive insertion of the ReLARC device via hysteroscopy, allowing direct visualization of the procedure.
1 insertion visit (in-person)
Duration - 3 years
Participants are followed for up to 3 years to monitor positioning, satisfaction, and device-related outcomes.
Multiple follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
S
Steven Weyers, MD
E
Eline Meireson, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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