Status:
COMPLETED
Usability, Safety and Efficacy of AspivixTM (Comparative Study)
Lead Sponsor:
Aspivix SA
Conditions:
IUD Insertion
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are t...
Eligibility Criteria
Inclusion
- Participants older than 18 years
- Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
- Participants able to provide informed consent as documented by signature with at least 24 hours of reflection time
- Good understanding of written and oral speaking used at the centre where the study will be carried out.
Exclusion
- Participants who are contraindicated for the insertion of the IUD Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
- Participants under use of excessive alcohol, narcotics or benzodiazepines prior to procedure
- Participants who do not wish to be informed of a chance discovery
- Participant receiving anaesthetics prior to IUD insertion procedure
- Participants on anticoagulant medication
- Participants under use of an analgesic (\< 12 hours)
- Previous cervical operation
- Severe vaginal bleeding of unknown origin
- Participant previously enrolled in this study
- Cervix diameter smaller than 26 mm
- Nabothian cyst
- Cervical myomas
- Cervical condylomas
- Squamous intraepithelial lesion (Cervical dysplasia)
- Cervical endometriosis
- Cervical tears
- A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
- Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
- Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
- Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04441281
Start Date
April 30 2021
End Date
February 15 2022
Last Update
February 15 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
HUG - Department Women, Child & Adolescent
Geneva, Canton of Vaud, Switzerland, 1205
2
Department Women, Mother & Child, University Hospital
Lausanne, Canton of Vaud, Switzerland, 1011