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Usability, Safety and Efficacy of AspivixTM | Clinical Trials | Clareo Health

COMPLETEDNA

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)

NCT04441333•Aspivix SA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Participants older than 18 years
•Participants presenting at the outpatient clinic for Mirena IUD insertion.
•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.

Exclusion Criteria

•Participants who are contraindicated for the insertion of the IUD Mirena
•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
•Previous cervical operation
•Severe vaginal bleeding
•Participant previously enrolled in this study
•Cervix diameter smaller than 26 mm
+11 more criteria

Locations (1)

Department Women, Mother & Child, University Hospital

Lausanne, Canton of Vaud, Switzerland

Key Dates

Start Date

July 1, 2020

Primary Completion Date

December 2, 2020

Completion Date

December 2, 2020

Last Updated

December 11, 2020

Enrollment

ACTUAL participants

Conditions

IUD Insertion

Interventions

AspivixTM cervical vacuum tenaculum

DEVICE

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

NCT05875571

IUDHealthy Female+2 more

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COMPLETEDNA

Ultrasound-guided IUD Insertion During Family Medicine Residency Training

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IUD Insertion Complication

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Usability, Safety and Efficacy of AspivixTM

Inclusion Criteria

Exclusion Criteria

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

Ultrasound-guided IUD Insertion During Family Medicine Residency Training

The Effectiveness of Music on Pain and Anxiety in IUD Insertion

Postplacental LNG-IUD Ultrasound Use Study

Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

Comparing Expulsion Rates for Different Intrauterine Device Insertion Techniques