Completed

NCT Number: NCT04441333

Usability, Safety and Efficacy of AspivixTM

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.

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Key information

Conditions

IUD Insertion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department Women, Mother & Child, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AspivixTM cervical vacuum tenaculum

Device

Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum

Primary outcomes

Usability and efficacy from the practitioner's perspective: questionnaire

Time frame: 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 outcomes

Participant's reported pain: Visual Analogue Scale

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

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aspivix SA

Industry

Registry information

Official study title

Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Pilot)

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 22, 2020
Registry last updated: Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed