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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Positioning of the ReLARC IUD
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 48 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Pregnancy
Arms & Interventions
ReLARC 3
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.
ReLARC® 3 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select).
Intervention: ReLARC (Device)
ReLARC 10
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.
ReLARC® 10 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select).
Intervention: ReLARC (Device)
Outcomes
Primary Outcomes
Positioning of the ReLARC IUD
Time Frame: 3 years
To evaluate the position of the ReLARC® IUD to confirm the succesful placement of the IUD with the ReLARC inserter during every follow-up visit.
Secondary Outcomes
- Expulsion rate(7 years)
- Ease of insertion(During Insertion visit)
- Learning curve of ReLARC insertion(During Insertion visit)
- patient satisfactory(3 years after insertion)
- Uterine cavity transverse diameter(During insertion visit)
- Ease of removal(7 years)
- Removal rate(7 years)
- Pain at removal(7 years)
- Pain score(During Insertion visit)