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.

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Contraception

Treatments: Device: ReLARC

Study type: Interventional

Funder types: Other

Identifiers

NCT05702281

REL-005

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

ReLARC 3

Other group

Description:

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).

Treatment:

Device: ReLARC

ReLARC 10

Other group

Description:

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).

Treatment:

Device: ReLARC