Status:
COMPLETED
Usability, Safety and Efficacy of AspivixTM
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 for Mirena IUD insertion.
- 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
- 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
- Previous cervical operation
- Severe vaginal bleeding
- Participant previously enrolled in this study
- Cervix diameter smaller than 26 mm
- Mullerian anomalies with two cervices
- 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 :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04441333
Start Date
July 1 2020
End Date
December 2 2020
Last Update
December 11 2020
Active Locations (1)
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1
Department Women, Mother & Child, University Hospital
Lausanne, Canton of Vaud, Switzerland, 1011