Usability, Safety and Efficacy of AspivixTM

Aspivix

Status

Completed

Conditions

IUD Insertion

Treatments

Device: AspivixTM cervical vacuum tenaculum

Study type

Interventional

Funder types

Industry

Identifiers

NCT04441333

Aspivix_IUD2019_Pilot

Details and patient eligibility

About

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 traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up.

AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber.

The aim of our pilot study is to assess the usability, safety and efficacy of the device.

Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding comparative study is registered separately.

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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