Status:
TERMINATED
Study to Evaluate the Learning Curve to Anchor GYN-CS® Device
Lead Sponsor:
University Hospital, Ghent
Conditions:
Learning Curve
Caesarean Section
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief 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 o...
Detailed Description
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®. Provid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04435496
Start Date
May 5 2020
End Date
June 7 2024
Last Update
June 12 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000