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.

University Hospital, Ghent120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Contraception

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

Ease of insertion

1\. The ease of the insertion (hysteroscope and ReLARC® device) by the following scale: 1. Insertion went smoothly. 2. I had little trouble while inserting the device but experienced this as a not important delay in my surgical act. 3. Insertion was rather difficult. 4. Insertion was time consuming, difficult, and dangerous. 5. Insertion was not possible due to technical issues or medical reasons.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 3 years after insertion

Uterine cavity transverse diameter

the uterine cavity transverse diameter (UCTD) (before ReLARC® device insertion) will be described.

Time frame: During insertion visit

Expulsion rate

The number of expulsions of the IUD will be registered during the trial

Time frame: 7 years

Removal rate

The number of early removal of the IUD will be registered during the trial

Time frame: 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

Time frame: 7 years

Pain at removal

pain (VAS): 1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain

Time frame: 7 years

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.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts