Usability, Safety and Efficacy of AspivixTM

Not Applicable

Completed

• Conditions: IUD Insertion
• Interventions: Device: AspivixTM cervical vacuum tenaculum

• Registration Number: NCT04441333
• Lead Sponsor: Aspivix SA

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2020-07-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-02
• Study Completion: 2020-12-02
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AspivixTM cervical vacuum tenaculum	AspivixTM cervical vacuum tenaculum	Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum.

Primary Outcome Measures

Name	Time	Method
Usability and efficacy from the practitioner's perspective: questionnaire	Right after the use of the device (right after the end of the procedure to insert the IUD).	The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.

Secondary Outcome Measures

Name	Time	Method
Participant's reported pain: Visual Analogue Scale	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	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.
Assessment of patient's satisfaction: questionnaire	Right after the use of the device (right after the end of the procedure to insert the IUD).	5 point Likert 'Patient Satisfaction Questionnaire' Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree".
The number of placement attempts before traction can be applied	During the procedure to insert the IUD which should last less than 5 minutes.	The number of placement attempts before traction of the cervix can be applied will be recorded
The number of spontaneous releases during traction	During the procedure to insert the IUD which should last less than 5 minutes.	The number of spontaneous releases during traction of the cervix will be recorded
Assessment of bleeding	During the procedure to insert the IUD which should last less than 5 minutes.	To assess bleeding, every buffer will be weighted, and the blank weight subtracted. Weight in mg will be reported in the case report form.
Assessment of adverse events	During the procedure to insert the IUD which should last less than 5 minutes.	Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)
Assessment of device deficiencies	During the procedure to insert the IUD which should last less than 5 minutes.	Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency)
Identification of new risks	During the procedure to insert the IUD which should last less than 5 minutes.	Safety of the procedure will be assessed by identifying and documenting any new risk.

Trial Locations

Locations (1)

Department Women, Mother & Child, University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland