Usability, Safety and Efficacy of AspivixTM (Comparative Study)

NCT04441281 | Completed

• 1 other identifier: Aspivix_IUD2019_Comparative
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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 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.

Conditions

IUD Insertion

Outcome Measures

Primary Outcomes (7)

• Patient-reported pain: Visual Analogic Scale

  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.

  Before the procedure

• Patient-reported pain: Visual Analogic Scale

  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.

  During speculum insertion

• Patient-reported pain: Visual Analogic Scale

  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.

  During AspivixTM / standard tenaculum application

• Patient-reported pain: Visual Analogic Scale

  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.

  During application of cervical traction

• Patient-reported pain: Visual Analogic Scale

  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.

  During IUD insertion

• Patient-reported pain: Visual Analogic Scale

  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.

  During AspivixTM / standard tenaculum release

• Patient-reported pain: Visual Analogic Scale

  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.

  5 minutes after the end of the procedure

Secondary Outcomes (7)

• 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 spontaneous releases

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

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

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

• Assessment of bleeding

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

• Assessment of adverse events

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

Study Arms (2)

Single-tooth tenaculum (Pozzi forceps)

ACTIVE COMPARATOR

In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix.

Procedure: Traction of the cervix for IUD insertion

AspivixTM cervical vacuum tenaculum

EXPERIMENTAL

In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix.

Procedure: Traction of the cervix for IUD insertion

Interventions

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).

AspivixTM cervical vacuum tenaculum; Single-tooth tenaculum (Pozzi forceps)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspivix SA: lead

Study Sites (2)

HUG - Department Women, Child & Adolescent

Geneva, Canton of Vaud, 1205, Switzerland

Location

Department Women, Mother & Child, University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Study Officials

• Patrice Mathevet, Prof.

  DFME CHUV Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded - Participants will be blinded towards the intervention used. Additionally, the type of device used will only be revealed to the practitioner after randomization, immediately prior IUD insertion.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 22, 2020
• Study Start: April 30, 2021
• Primary Completion: February 14, 2022
• Study Completion: February 15, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CH (2)