Study to Evaluate the Learning Curve to Anchor GYN-CS® Device (NCT04435496) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate the Learning Curve to Anchor GYN-CS® Device
Stopped: slow recruitment rate
Belgium7 participantsStarted 2020-05-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 48 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analyse the learning curve of the placement of the IUD by the surgeon
Timeframe: During the placement of the IUD
2
Analyse the learning curve of the placement of the IUD by the surgeon