Learning CurveGYN-CS-106NCT04435496
Study to Evaluate the Learning Curve to Anchor GYN-CS® Device
A study testing GYN-CS in people with Learning Curve and Caesarean Section, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Learning Curve, Caesarean Section, Intra-uterine Device
- What is being tested?
- GYN-CS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 5 May 2020to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- GYN-CS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYN-CSDevice
placement of the GYN-CS device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: GYN-CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: During the placement of the IUD
Secondary outcomes (6)
Safety of insertion
All complications during the insertion of the IUD will be saved in a log
Measured: 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.
Measured: 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?
Measured: 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
Measured: 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
Measured: 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)
Measured: 3 years after insertion of the IUD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start5 May 2020
- Primary completion31 May 2023
- Study completion7 Jun 2024
Why it stopped: slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning CurveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristien Roelens, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435496
- Sponsor's protocol ID
- BC-07362
- Acronym
- GYN-CS-106
- Status last verified
- Jun 2024
- First submitted
- 11 May 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04435496
- Acronym / sponsor ID
- GYN-CS-106 / BC-07362
- Conditions
- Learning Curve, Caesarean Section, Intra-uterine Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment rate
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be conducted in 20 healthy women between 18 and 48 years scheduled for elective Caesarean section.
| Arm | Type | Receives |
|---|---|---|
| GYN-CS insertion | Other | Device: GYN-CSGYN-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. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GYN-CSplacement of the GYN-CS device | Device | GYN-CS insertion |
Primary outcome
Analyse the learning curve of the placement of the IUD by the surgeon
Time frame: During the placement of the IUD
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
Analyse the learning curve of the placement of the IUD by the surgeon
Time frame: During the placement of the IUD
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.
Ease of insertion of the IUD
Time frame: During the placement 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
6 secondary outcomes
Safety of insertion
Time frame: During the insertion of the device until the end of the procedure of IUD placement
Expulsion rate and causes
Time frame: During the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
Continuation rate
Time frame: during the whole duration of the trial (from the insertion of the IUD until 3 years of follow-up)
Patient satisfaction: Likert scale
Time frame: 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
Time frame: 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
Time frame: 3 years after insertion of the IUD
Results and safety
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristien Roelens, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GYN-CS in people with Learning Curve and Caesarean Section, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse the learning curve of the placement of the IUD by the surgeon (time frame: During the placement of the IUD). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.