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

NCT ID: NCT04435496

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2024-06-07

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.

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®. 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.

Conditions

Learning Curve; Caesarean Section; Intra-uterine Device

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

GYN-CS insertion

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.

Group Type: OTHER

GYN-CS

Intervention Type: DEVICE

placement of the GYN-CS device

Interventions

GYN-CS

placement of the GYN-CS device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristien Roelens, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-07362

Identifier Type: -

Identifier Source: org_study_id