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Usability, Safety and Efficacy of AspivixTM

NCT04441333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-12-11

No results posted yet for this study

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

DEVICE

AspivixTM cervical vacuum tenaculum

Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum

Sponsors & Collaborators

  • Aspivix SA

    lead INDUSTRY

Principal Investigators

  • Patrice Mathevet, Prof. · DFME CHUV Lausanne

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-02
Completion
2020-12-02

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04441333 on ClinicalTrials.gov