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

NCT04435496 | Terminated

• 1 other identifier: BC-07362
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Learning Curve; Caesarean Section; Intra-uterine Device

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Safety of insertion

  During the insertion of the device until the end of the procedure of IUD placement

• Expulsion rate and causes

  During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)

• Continuation rate

  during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)

• Patient satisfaction: Likert scale

  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 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)

Study Arms (1)

GYN-CS insertion

OTHER

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

Interventions

GYN-CS DEVICE

placement of the GYN-CS device

GYN-CS insertion

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy, women,
• Pregnant women in the second trimester
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

• Kristien Roelens, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 17, 2020
• Study Start: May 5, 2020
• Primary Completion: May 31, 2023
• Study Completion: June 7, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)