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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Contraception

Intervention / Treatment
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* Device: ReLARC


Participation Criteria
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Eligibility Criteria
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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 year 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 Thrombophlebitis, thrombosis, or thromboembolic disorders Cerebrovascular accident, stroke, or transient ischemic attack Any cardiac, renal, or hepatic disease Subjects receiving corticosteroid therapy or immunosuppressive drugs Morbus Wilson AIDS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ReLARC 3<br>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<br>* 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.<br>|
| Other: ReLARC 10<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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copper intra-uterine device, Hysteroscope