IUD InsertionNCT04441333
Usability, Safety and Efficacy of AspivixTM
A study testing AspivixTM cervical vacuum tenaculum in people with IUD Insertion, run by Aspivix SA at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion
- What is being tested?
- AspivixTM cervical vacuum tenaculum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department Women, Mother & Child, University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Official title: Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Pilot)
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.
Read more
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.
- Conditions
- IUD Insertion
- Being tested
- AspivixTM cervical vacuum tenaculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspivixTM cervical vacuum tenaculumDevice
Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum
| Study group | Role | What they receive |
|---|---|---|
| AspivixTM cervical vacuum tenaculum | Experimental | Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum. Receives: Device: AspivixTM cervical vacuum tenaculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Right after the use of the device (right after the end of the procedure to insert the IUD).
Secondary outcomes (8)
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.
Measured: 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
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".
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: During the procedure to insert the IUD which should last less than 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jul 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IUD InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study: single-arm non-comparative study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspivix SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice Mathevet, Prof., Principal investigator, DFME CHUV Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441333
- Sponsor's protocol ID
- Aspivix_IUD2019_Pilot
- Status last verified
- Dec 2020
- First submitted
- 15 Jun 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35004719
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability, Safety and Efficacy of AspivixTM, an Atraumatic Innovative Uterine Cervical Traction Device: a Pilot Phase Followed by a Comparative Study (Pilot)
- ClinicalTrials.gov ID
- NCT04441333
- Acronym / sponsor ID
- Aspivix_IUD2019_Pilot
- Conditions
- IUD Insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aspivix SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study: single-arm non-comparative study
| Arm | Type | Receives |
|---|---|---|
| AspivixTM cervical vacuum tenaculum | Experimental | Device: AspivixTM cervical vacuum tenaculumTraction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspivixTM cervical vacuum tenaculumTraction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum | Device | AspivixTM cervical vacuum tenaculum |
Primary outcome
Usability and efficacy from the practitioner's perspective: questionnaire
Time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).
The practitioner will assess the usability and efficacy of the Investigational Device using a 5 point Likert 'Usability and Efficacy Questionnaire'.
8 secondary outcomes
Participant's reported pain: Visual Analogue Scale
Time frame: 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
Assessment of patient's satisfaction: questionnaire
Time frame: 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
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
The number of spontaneous releases during traction
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
Assessment of bleeding
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
Assessment of adverse events
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
Assessment of device deficiencies
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
Identification of new risks
Time frame: During the procedure to insert the IUD which should last less than 5 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 35004719Legardeur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Mathevet, Prof. principal investigator
DFME CHUV Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AspivixTM cervical vacuum tenaculum in people with IUD Insertion, run by Aspivix SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and efficacy from the practitioner's perspective: questionnaire (time frame: Right after the use of the device (right after the end of the procedure to insert the IUD).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.