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
295 weeks
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
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.
CONDITIONS
Official 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, 18 to 48 years old, without contraindications for hysteroscopy
- Willing to attend follow-up visits
- Willing to avoid intercourse for 2 weeks and not use tampons or menstrual cups for 2 months after insertion
- Signed written informed consent
- Uterine fundus thickness of 11mm or more
You will not qualify if you...
- T or Y shaped uterus
- Dysmorphic uterus (U1) or abnormal myometrium
- Complete septate uterus (U2b)
- Bicorporal uterus (U3-U6)
- Use of injectable contraceptives in last 6 months
- Uterine infection, clinical cervicitis, or vaginitis
- Intrauterine fibroids (intramural, intracavitary, or submucosal)
- Cancer or other uterine diseases
- Any malignancy or treatments for malignancy including melanoma or gynecological cancer
- Blood clotting disorders
- Intrauterine polyps
- Receiving corticosteroid or immunosuppressive therapy
- Morbus Wilson
- AIDS
- Pregnancy
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Trial Site Locations
Total: 1 location
1
University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
S
Steven Weyers, MD
CONTACT
E
Eline Meireson, Msc
CONTACT
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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