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. (ReLARC)

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 Overview

• Status: Recruiting
• Conditions: Contraception
• Intervention / Treatment: Device: ReLARC

Detailed Description

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 in the Women's Clinic of the Ghent University Hospital in Belgium (International Coordinating Centre) and in 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. During the screeningsvisit the physician will introduce the trial. During the enrolment visit, the patient will sign the informed consent if she agrees to participate. During the insertion visit, the IUD will be placed, the correct location of the device will be determined, the ease of ReLARC insertion and hysteroscope insertion will be measured, the learning curve of the insertion will be registered and the pain score of the patient will be registered.

After 4-8 weeks the first follow-up visit will take place. The location of the device will be determined and a satisfactory score of the patient about the IUD. During 3 years there's a yearly consultation with the gynaecologist where the location of the device and the satisfactory score about the IUD will be determined.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Weyers, MD; Phone Number: 0032 93327817; Email: steven.weyers@uzgent.be
• Study Contact Backup: Name: Eline Meireson, Msc; Phone Number: 0032 09 332 78 17; Email: eline.meireson@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • University Hospital
    • Contact: Eline Meireson; Phone Number: +32 9 332 78 17; Email: eline.meireson@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Device: 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.
Other: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion	1. The ease of the insertion (hysteroscope and ReLARC® device) by the following scale: Insertion went smoothly.; I had little trouble while inserting the device but experienced this as a not important delay in my surgical act.; Insertion was rather difficult.; Insertion was time consuming, difficult, and dangerous.; Insertion was not possible due to technical issues or medical reasons.	During Insertion visit
Learning curve of ReLARC insertion	2. The learning curve of ReLARC® insertion, that starts after introducing the scope in the cervix and ends when the thread is cut and looped. This will be reported in minutes.	During Insertion visit
Pain score	the participant's pain by a Visual Analogue Scale-VAS (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain) will be described.	During Insertion visit
patient satisfactory	The patient satisfactory score will be determined at every follow-up visit (4-8 weeks after insertion; 1 year after insertion, 2 years after insertion and 3 years after insertion)	3 years after insertion
Uterine cavity transverse diameter	the uterine cavity transverse diameter (UCTD) (before ReLARC® device insertion) will be described.	During insertion visit
Expulsion rate	The number of expulsions of the IUD will be registered during the trial	7 years
Removal rate	The number of early removal of the IUD will be registered during the trial	7 years
Ease of removal	The ease of removal (Likert scale): 1. very easy, 2. easy, 3. neither easy nor difficult, 4. difficult, 5. very difficult	7 years
Pain at removal	pain (VAS): 1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain	7 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: copper intra-uterine device; Hysteroscope
• Other Study ID Numbers: REL-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No