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| Name | Class |
|---|---|
| Federico II University | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReLARC | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of insertion | 1. The ease of the insertion (hysteroscope and ReLARC® device) by the following scale:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Weyers, MD | Contact | 93327817 | 0032 | steven.weyers@uzgent.be |
| Eline Meireson, Msc | Contact | 09 332 78 17 | 0032 | eline.meireson@uzgent.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Ghent | 9000 | Belgium |
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| 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 |