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NCT04441333
Usability, Safety and Efficacy of AspivixTM
NA trial testing AspivixTM cervical vacuum tenaculum in IUD Insertion in 13 participants. Completed in 2 December 2020.
2 December 2020
Quick facts
| Lead sponsor | Aspivix SA |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 13 |
| Start date | 1 July 2020 |
| Primary completion | 2 December 2020 |
| Estimated completion | 2 December 2020 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- AspivixTM cervical vacuum tenaculum
Conditions studied
- IUD Insertion — all drugs for IUD Insertion →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04441333
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Aspivix SA trials
Trials by the same sponsor.
- NCT04441281 — Usability, Safety and Efficacy of AspivixTM (Comparative Study) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04441333 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aspivix SA
- Last refreshed: 11 December 2020
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