Usability, Safety and Efficacy of AspivixTM

Aspivix SA13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

IUD Insertion

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Usability and efficacy from the practitioner's perspective: questionnaire

The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.

Time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).

Secondary Outcomes

Participant's reported pain: Visual Analogue Scale

Participant's reported pain will be assessed by the patient using a 100-point Visual Analogue Scale (VAS) at specific steps during IUD insertion Minimum and maximum values range from 0 to 100, the higher score being the better outcome.

Time frame: Before the procedure, during speculum insertion, during AspivixTM vacuum application, during application of cervical traction, during IUD insertion, during AspivixTM release, 5 minutes after the end of the procedure

Assessment of patient's satisfaction: questionnaire

5 point Likert 'Patient Satisfaction Questionnaire' Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree".

Time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).

The number of placement attempts before traction can be applied

The number of placement attempts before traction of the cervix can be applied will be recorded