Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2020-07-01
2020-12-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AspivixTM cervical vacuum tenaculum
Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum.
AspivixTM cervical vacuum tenaculum
Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AspivixTM cervical vacuum tenaculum
Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
* Mullerian anomalies with two cervices
* Nabothian cyst
* Cervical myomas
* Cervical condylomas
* Squamous intraepithelial lesion (Cervical dysplasia)
* Cervical endometriosis
* Cervical tears
* A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
* Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
* Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
* Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aspivix SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrice Mathevet, Prof.
Role: PRINCIPAL_INVESTIGATOR
DFME CHUV Lausanne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department Women, Mother & Child, University Hospital
Lausanne, Canton of Vaud, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Legardeur H, Masiello-Fonjallaz G, Jacot-Guillarmod M, Mathevet P. Safety and Efficacy of an Atraumatic Uterine Cervical Traction Device: A Pilot Study. Front Med (Lausanne). 2021 Dec 23;8:742182. doi: 10.3389/fmed.2021.742182. eCollection 2021.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Aspivix_IUD2019_Pilot
Identifier Type: -
Identifier Source: org_study_id