Clinical trial NCT04441333: Usability, Safety and Efficacy of AspivixTM
Official title: Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion
Lead sponsor: Aspivix SA
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study: single-arm non-comparative study
Primary purpose: OTHER

Brief 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 criteria: 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
* 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

Primary outcomes:
measure: Usability and efficacy from the practitioner's perspective: questionnaire
timeFrame: Right after the use of the device (right after the end of the procedure to insert the IUD).
Secondary outcomes:
measure: Participant's reported pain: Visual Analogue Scale
timeFrame: Before the procedure, during speculum insertion, during AspivixTM vacuum application, during application of cervical traction, during IUD insertion, during AspivixTM release, 5 minutes after the end of the procedure
measure: Assessment of patient's satisfaction: questionnaire
timeFrame: Right after the use of the device (right after the end of the procedure to insert the IUD).
measure: The number of placement attempts before traction can be applied
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: The number of spontaneous releases during traction
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: Assessment of bleeding
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: Assessment of adverse events
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: Assessment of device deficiencies
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: Identification of new risks
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department Women, Mother & Child, University Hospital
state: Vaud
Study officials:
affiliation: DFME CHUV Lausanne
name: Patrice Mathevet, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.