NCT04441281

Usability, Safety and Efficacy of AspivixTM (Comparative Study)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Aspivix SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-02-14
• Completion: 2022-02-15
• First posted: 2020-06-22
• Last updated: 2022-02-15

Locations

2 sites across 1 country: Switzerland