Study to Evaluate the Learning Curve to Anchor GYN-CS® Device (GYN-CS-106)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Caesarean Section; Learning Curve; Intra-uterine Device
• Intervention / Treatment: Device: GYN-CS

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eline Meireson, Msc; Phone Number: 09/332 78 17; Email: eline.meireson@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Eline Meireson; Phone Number: 09/332 78 17; Email: eline.meireson@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: GYN-CS; placement of the GYN-CS device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Kristien Roelens, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BC-07362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No