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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AspivixTM cervical vacuum tenaculum | Experimental | Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AspivixTM cervical vacuum tenaculum | Device | Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability and efficacy from the practitioner's perspective: questionnaire | The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'. | Right after the use of the device (right after the end of the procedure to insert the IUD). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's reported pain: Visual Analogue Scale | Participant's reported pain will be assessed by the patient using a 100-point Visual Analogue Scale (VAS) at specific steps during IUD insertion Minimum and maximum values range from 0 to 100, the higher score being the better outcome. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrice Mathevet, Prof. | DFME CHUV Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Women, Mother & Child, University Hospital | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35004719 | Derived | 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. |
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Pilot study: single-arm non-comparative study
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| Assessment of patient's satisfaction: questionnaire | 5 point Likert 'Patient Satisfaction Questionnaire' Minimal to maximal values range from 1 to 5, 1 meaning "disagree" and 5 "agree". | Right after the use of the device (right after the end of the procedure to insert the IUD). |
| The 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 during traction | 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 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 of the deficiency) | 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. |