Study to Evaluate the Learning Curve to Anchor GYN-CS® Device

Study Overview
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Brief Summary
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GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are: Analyse the learning curve of the surgeon and the ease of insertion of the device.

Detailed Description
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This study is a mono-center, open-label, single-arm (non-randomized trial, in which each participant receives GYN-CS® 3 or GYN-CS® 10) prospective study for the insertion evaluation of GYN-CS®. Providing no complications occur, the women will remain in the study for 3 years. The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section. The learning curve parameters are the time of the procedure (starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted) and a scale for the ease of insertion of the device. Following insertion of GYN-CS® 3 and 10, women will be reexamined at discharge, at 6-8 weeks, at 1, 2 and 3 years after insertion. At 3 years after insertion of the GYN-CS® 3, it will be removed during the follow-up visit. At 3 years after insertion of the GYN-CS® 10, the device doesn't need to be removed at the follow-up visit. During every visit a vaginal ultrasound and gynecological examination are performed as well as a satisfactory scale of the IUD is questioned at the patient.

Official Title
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Study to Evaluate the Learning Curve to Anchor a Frameless Copper-releasing Device (GYN-CS®) During Caesarean Section With a Follow-up of 3 Years Study

Conditions
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Learning Curve, Caesarean Section, Intra-uterine Device

Intervention / Treatment
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* Device: GYN-CS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy, women, Pregnant women in the second trimester 18-48 years of age Birth by Caesarean section planned Be willing to stay in the study for 3 years Return for follow-up at the designated times Signed informed consent Exclusion Criteria: The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out) Suspicion of endometrial or uterine pathology such as congenital malformation of the uterus Large uterine fibromata (> 3 cm in diameter) Acute leukemia Severe blood clotting disorders and undiagnosed genital tract bleeding Significant medical disease that in the medical opinion of the investigator is likely to interfere with patient ability to complete the entire trial Participants receiving corticosteroid therapy (hydrocortisone>40mg/d or an equivalent) or immunosuppressive drugs Caesarean section < 36 weeks

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GYN-CS insertion<br>GYN-CS device will be inserted in women during their c-section. The study patient can chose between a lifespan of 3 years (GYN-CS 3) and a lifespan of 10 years (GYN-CS 10) of the device. | Device: GYN-CS<br>* placement of the GYN-CS device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyse the learning curve of the placement of the IUD by the surgeon | procedure time: the time of the device placement starts after removal of the placenta when the uterus is completely empty and ends when the device is correctly inserted | During the placement of the IUD | 
| Analyse the learning curve of the placement of the IUD by the surgeon | successful insertion with adequate position during follow-up evaluations. The adequate position of the IUD will be checked by visualisation of the IUD by performing a vaginal ultrasound. | During the placement of the IUD | 
| Ease of insertion of the IUD | The ease of insertion of the IUD will be measured, using the following scale: 1. The insertion of the device went smoothly 2. I had little trouble inserting the device, but experienced this as a not important delay in my surgical act 3. The insertion of the device was rather difficult 4. The insertion of the device was time consuming, difficult and dangerous 5. The insertion of the device wasn't possible due to technical issues or medical reasons | During the placement of the IUD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of insertion | All complications during the insertion of the IUD will be saved in a log | During the insertion of the device until the end of the procedure of IUD placement | 
| Expulsion rate and causes | At every follow-up visit, expulsion of the IUD will be asked and the reason will be described in a log. | During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up) | 
| Continuation rate | What is the reason for drop-out of the study? | during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up) | 
| Patient satisfaction: Likert scale | Patient satisfaction by Likert scale at every follow up: very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. At removal, the ease of this action by the following scale for the physicians: 1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act 2. The removal of the device went smoothly 3. The removal of the device was rather difficult 4. The removal of the device was time consuming, difficult and dangerous 5. The removal of the device wasn't possible due to technical issues or medical reasons | at every follow-up visit during the trial (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD) | 
| Ease if removal of the IUD | At removal, the ease of this action by the following scale for the physicians: 1. I had little trouble with removing the device, but experienced this as a not important delay in my surgical act 2. The removal of the device went smoothly 3. The removal of the device was rather difficult 4. The removal of the device was time consuming, difficult and dangerous 5. The removal of the device wasn't possible due to technical issues or medical reasons | at every follow-up visite (4 days after the insertion of the IUD, 6-8 weeks after placement, 1 year after placement, 2 years after placement, 3 years after placement of the IUD) | 
| The pain of the patient during removal of the IUD: VAS scale | The pain will be measured using a VAS scale (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain) | 3 years after insertion of the IUD |