Usability, Safety and Efficacy of AspivixTM (Comparative Study)

Study Overview
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Brief Summary
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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.

Official Title
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Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Comparative)

Conditions
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IUD Insertion

Intervention / Treatment
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* Procedure: Traction of the cervix for IUD insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single-tooth tenaculum (Pozzi forceps)<br>In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix. | Procedure: Traction of the cervix for IUD insertion<br>* Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).<br>|
| Experimental: AspivixTM cervical vacuum tenaculum<br>In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix. | Procedure: Traction of the cervix for IUD insertion<br>* Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | Before the procedure | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During speculum insertion | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During AspivixTM / standard tenaculum application | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During application of cervical traction | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During IUD insertion | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | During AspivixTM / standard tenaculum release | 
| Patient-reported pain: Visual Analogic Scale | Patient-reported pain scores (VAS) at specific time points during IUD insertion procedure Minimal and maximal values range from 0 to 100, the higher being the better outcome. | 5 minutes after the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of placement attempts before traction can be applied | number of placement attempts before traction can be applied The number of placement attempts before traction of the cervix can be applied will be recorded | During the procedure to insert the IUD which should last less than 5 minutes. | 
| The number of spontaneous releases | The number of spontaneous releases during traction of the cervix will be recorded | During the procedure to insert the IUD which should last less than 5 minutes. | 
| Assessment of the efficacy of the investigational device and its comparator by the practitioner | 5 point Likert 'Efficacy Questionnaire' will be used. Minimal to maximal values range from 1 to 5, 1 meaning disagree and 5 agree. | During the procedure to insert the IUD which should last less than 5 minutes. | 
| Assessment of bleeding | To assess bleeding, every buffer will be weighted, and the blank weight subtracted. Weight in mg will be reported in the case report form. | During the procedure to insert the IUD which should last less than 5 minutes. | 
| Assessment of adverse events | Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants) | During the procedure to insert the IUD which should last less than 5 minutes. | 
| Assessment of device deficiencies | Safety of the procedure will be assessed by documenting device deficiencies (description) | During the procedure to insert the IUD which should last less than 5 minutes. | 
| Identification of new risks | Safety of the procedure will be assessed by identifying and documenting any new risk. | During the procedure to insert the IUD which should last less than 5 minutes. |