NCT04441333

Usability, Safety and Efficacy of AspivixTM

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (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 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.

Conditions

• IUD Insertion

Interventions

Type	Name	Description
DEVICE	AspivixTM cervical vacuum tenaculum	Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-12-02
• Completion: 2020-12-02
• First posted: 2020-06-22
• Last updated: 2020-12-11

Locations

1 site across 1 country: Switzerland