GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance

NCT01979835 | Completed Results

• 1 other identifier: 130717
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

intrauterine device, contraception

Outcome Measures

Primary Outcomes (1)

• Serosal-anchor Measurement

  endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus

  6-8 weeks

Secondary Outcomes (1)

• Complications

  5 years

Study Arms (1)

GF

EXPERIMENTAL

Women who have a GyneFix Viz inserted

Device: GyneFix Viz

Interventions

GyneFix Viz DEVICE

insertion of GyneFix Viz and measurment of the SA distance

GF

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
• Immediately after a pregnancy interruption \> 10 weeks gestation

Sponsors & Collaborators

• Wiebe, Ellen, M.D.: lead

Study Sites (1)

Willow Women's Clinic

Vancouver, British Columbia, V5Z1H9, Canada

Location

Results Point of Contact

• Title: Ellen Wiebe
• Organization: principal investigator

ellenwiebe@gmail.com

6047095611

Study Officials

• Ellen R WIEBE, MD

  University of BC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 26, 2013
• First Posted: November 8, 2013
• Study Start: February 1, 2013
• Primary Completion: March 3, 2015
• Study Completion: March 3, 2020
• Last Updated: April 28, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Locations

CA (1)