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.

Last updated: January 22, 2025
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

Contraception

Treatment

ReLARC

Clinical Study ID

NCT05702281
REL-005
  • Ages 18-48
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Generally healthy women, 18 - 48 years of age and not having a contraindication forhysteroscopy

  • Be willing to come back for the follow-ups

  • Be willing to refrain from having intercourse the first two weeks and using tamponsand menstrual cups in the first 2 months, following insertion

  • Sign a written informed consent

  • Fundus thickness should be 11mm or more

Exclusion

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 (infectionshould 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 atany time excludes the subject

  • Blood clotting disorders

  • Intrauterine polyps

  • Subjects receiving corticosteroid therapy or immunosuppressive drugs

  • Morbus Wilson

  • AIDS

  • Pregnancy

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: ReLARC
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University Hospital

    Ghent, 9000
    Belgium

    Active - Recruiting

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