ContraceptionGFNCT01979835
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance
A study testing GyneFix Viz in people with Contraception, run by Wiebe, Ellen, M.D. at 1 site in Canada.
Trial summary
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- GyneFix Viz
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy women requesting intrauterine contraception
- willing to have a GyneFix IUD for pregnancy prevention
- able to return for a follow-up ultrasound
- able to read and understand consent form
Who cannot join
- Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
- Immediately after a pregnancy interruption > 10 weeks gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
- Conditions
- Contraception
- Being tested
- GyneFix Viz
- Keywords
- intrauterine device, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GyneFix VizDevice
insertion of GyneFix Viz and measurment of the SA distance
| Study group | Role | What they receive |
|---|---|---|
| GF | Experimental | Women who have a GyneFix Viz inserted Receives: Device: GyneFix Viz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serosal-anchor Measurement
endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus
Measured: 6-8 weeks
Secondary outcomes (1)
Complications
Number of participants with complications and removals at the end of the 5-year follow-up period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completion3 Mar 2015
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wiebe, Ellen, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen R WIEBE, MD, Principal investigator, University of BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979835
- Sponsor's protocol ID
- 130717
- Acronym
- GF
- Status last verified
- Apr 2020
- First submitted
- 26 Oct 2013
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION
- ClinicalTrials.gov ID
- NCT01979835
- Acronym / sponsor ID
- GF / 130717
- Conditions
- Contraception
- Keywords
- intrauterine device, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Wiebe, Ellen, M.D.University, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 3 Mar 2015 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GF | Experimental | Device: GyneFix VizWomen who have a GyneFix Viz inserted |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- healthy women requesting intrauterine contraception
- willing to have a GyneFix IUD for pregnancy prevention
- able to return for a follow-up ultrasound
- able to read and understand consent form
Key exclusion criteria (2 listed)
- Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
- Immediately after a pregnancy interruption > 10 weeks gestation
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 |
|---|---|---|
| GyneFix Vizinsertion of GyneFix Viz and measurment of the SA distance | Device | GF |
Primary outcome
Serosal-anchor Measurement
Time frame: 6-8 weeks
endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus
1 secondary outcome
Complications
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ellen R WIEBE, MD principal investigator
University of BC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GyneFix Viz in people with Contraception, run by Wiebe, Ellen, M.D. at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serosal-anchor Measurement (time frame: 6-8 weeks). 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 28 Apr 2020.