Usability, Safety and Efficacy of AspivixTM (Comparative Study)

IUD Insertion Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

IUD Insertion

Clinical Trial Details

NCT number	NCT04441281
Study type	Interventional
Source	Aspivix SA
Contact
Status	Completed
Phase	N/A
Start date	April 30, 2021
Completion date	February 15, 2022

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