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NCT04441333

Usability, Safety and Efficacy of AspivixTM

Completed NA Last updated 11 December 2020
What this trial tests

NA trial testing AspivixTM cervical vacuum tenaculum in IUD Insertion in 13 participants. Completed in 2 December 2020.

Timeline
1 July 2020
Primary endpoint
2 December 2020
2 December 2020

Quick facts

Lead sponsorAspivix SA
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment13
Start date1 July 2020
Primary completion2 December 2020
Estimated completion2 December 2020
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Aspivix SA

Who can join

18 and older, female only, with IUD Insertion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study.
    Legardeur H, Masiello-Fonjallaz G, Jacot-Guillarmod M, Mathevet P. · · 2021 · cited 3× · PMID 35004719 · DOI 10.3389/fmed.2021.742182

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Other Aspivix SA trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04441333.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing