Completed

NCT Number: NCT04441281

Usability, Safety and Efficacy of AspivixTM (Comparative Study)

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 comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).

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

HUG - Department Women, Child & Adolescent, Geneva, Canton of Vaud, 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 IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
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 (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
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 (< 12 hours)
Previous cervical operation
Severe vaginal bleeding of unknown origin
Participant previously enrolled in this study
Cervix diameter smaller than 26 mm
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

Traction of the cervix for IUD insertion

Procedure

Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).

Primary outcomes

Patient-reported pain: Visual Analogic Scale

Time frame: Before the procedure

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: During speculum insertion

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: During AspivixTM / standard tenaculum application

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: During application of cervical traction

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: During IUD insertion

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: During AspivixTM / standard tenaculum release

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.
Patient-reported pain: Visual Analogic Scale

Time frame: 5 minutes after the end of the procedure

Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome.

Secondary outcomes

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.

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
The number of spontaneous releases

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 the efficacy of the investigational device and its comparator by the practitioner

Time frame: During the procedure to insert the IUD which should last less than 5 minutes.

5 point Likert 'Efficacy Questionnaire' will be used. Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree".
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)
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 (Comparative)

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 22, 2020
Registry last updated: Feb 15, 2022

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.

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Completed