Clinical trial: Usability, Safety and Efficacy of AspivixTM (Comparative Study) (NCT04441281)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment