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.
NCT ID: NCT05702281
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-05-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
ReLARC
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
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).
ReLARC
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.
Interventions
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ReLARC
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
48 Years
FEMALE
Yes
Sponsors
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Federico II University
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REL-005
Identifier Type: -
Identifier Source: org_study_id
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