Clinical trial NCT04441281: Usability, Safety and Efficacy of AspivixTM (Comparative Study)
Official title: Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Comparative)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Insertion
Lead sponsor: Aspivix SA
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 comparative study is to assess the patient's pain and bleeding using the AspivixTM device in comparison with a commonly used single-tooth tenaculum (Pozzi forceps). Additionally, the comparative study aims to assess and compare the safety of the AspivixTM device with the single-tooth tenaculum (Pozzi forceps).

Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding pilot study is registered separately.


Eligibility criteria: Inclusion Criteria:

* Participants older than 18 years
* Participants presenting at the outpatient clinic IUD insertion of Mirena (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
* 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 (BAYER), Kyleena (BAYER), Jaydess (BAYER), NOVAT 380 (BAYER), NT Cu380 mini (MONALISA), NT Cu380 (MONALISA), CuT 380A (MONALISA) or CuT 380A QL (MONALISA).
* 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 (\< 12 hours)
* Previous cervical operation
* Severe vaginal bleeding of unknown origin
* Participant previously enrolled in this study
* Cervix diameter smaller than 26 mm
* 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: Patient-reported pain: Visual Analogic Scale
timeFrame: Before the procedure
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: During speculum insertion
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: During AspivixTM / standard tenaculum application
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: During application of cervical traction
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: During IUD insertion
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: During AspivixTM / standard tenaculum release
measure: Patient-reported pain: Visual Analogic Scale
timeFrame: 5 minutes after the end of the procedure
Secondary outcomes:
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
timeFrame: During the procedure to insert the IUD which should last less than 5 minutes.
measure: Assessment of the efficacy of the investigational device and its comparator by the practitioner
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: Geneva
country: Switzerland
facility: HUG - Department Women, Child & Adolescent
state: Vaud
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: