NCT05702281

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2022Dec 2027

First Submitted

Initial submission to the registry

June 22, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.7 years

First QC Date

June 22, 2021

Last Update Submit

January 22, 2025

Conditions

Contraception

Keywords

copper intra-uterine deviceHysteroscope

Outcome Measures

Primary Outcomes (1)

  • Positioning of the ReLARC IUD

    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.

    3 years

Secondary Outcomes (9)

  • Ease of insertion

    During Insertion visit

  • Learning curve of ReLARC insertion

    During Insertion visit

  • Pain score

    During Insertion visit

  • patient satisfactory

    3 years after insertion

  • Uterine cavity transverse diameter

    During insertion visit

  • +4 more secondary outcomes

Study Arms (2)

ReLARC 3

OTHER

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).

Device: ReLARC

ReLARC 10

OTHER

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).

Device: ReLARC

Interventions

ReLARCDEVICE

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 10ReLARC 3

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

RECRUITING

Central Study Contacts

Steven Weyers, MD

CONTACT

93327817steven.weyers@uzgent.be

Eline Meireson, Msc

CONTACT

09 332 78 17eline.meireson@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

January 27, 2023

Study Start

May 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)