IUD InsertionNCT04441281

Usability, Safety and Efficacy of AspivixTM (Comparative Study)

A study testing Traction of the cervix for IUD insertion in people with IUD Insertion, run by Aspivix SA at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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?: Traction of the cervix for IUD insertion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesSwitzerland
Study dates: 30 Apr 2021to 15 Feb 2022
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 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.

Who cannot join

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)

Show all 20Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

HUG - Department Women, Child & Adolescent
Geneva, Canton of Vaud, 1205
Department Women, Mother & Child, University Hospital
Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

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 (Comparative)

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.

Conditions: IUD Insertion
Being tested: Traction of the cervix for IUD insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Traction of the cervix for IUD insertionProcedure or surgery
Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).

Study groups in NCT04441281
Study group	Role	What they receive
Single-tooth tenaculum (Pozzi forceps)	Active comparator	In the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix. Receives: Procedure: Traction of the cervix for IUD insertion
AspivixTM cervical vacuum tenaculum	Experimental	In the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix. Receives: Procedure: Traction of the cervix for IUD insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes after the end of the procedure

Secondary outcomes (7)

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
Measured: 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
Measured: 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".
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)
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.

30 Apr 202115 Feb 2022

First posted22 Jun 2020
Study start30 Apr 2021
Primary completion14 Feb 2022
Study completion15 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04441281
Sponsor's protocol ID: Aspivix_IUD2019_Comparative
Status last verified: Feb 2022
First submitted: 15 Jun 2020
Last updated: 15 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years.
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Transcutaneous Electrical Nerve Stimulation for Pain Mitigation During Intrauterine Device Placement
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All IUD Insertion trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2022. 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 (Comparative)
ClinicalTrials.gov ID: NCT04441281
Acronym / sponsor ID: Aspivix_IUD2019_Comparative
Conditions: IUD Insertion
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Aspivix SAIndustry (pharma, biotech, devices)
Study start: 30 Apr 2021 (actual)
Primary completion: 14 Feb 2022 (actual)
Study completion: 15 Feb 2022 (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.

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.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Single-tooth tenaculum (Pozzi forceps)	Active comparator	Procedure: Traction of the cervix for IUD insertionIn the control arm, a single-tooth tenaculum, Pozzi forceps, used during routine IUD insertion, is employed to hold and stabilize the cervix.
AspivixTM cervical vacuum tenaculum	Experimental	Procedure: Traction of the cervix for IUD insertionIn the experimental arm, the investigational AspivixTM cervical vacuum tenaculum is employed to hold and stabilize the cervix.

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 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.

Key exclusion criteria (20 listed)

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

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
Traction of the cervix for IUD insertionLimited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).	Procedure or surgery	AspivixTM cervical vacuum tenaculum, Single-tooth tenaculum (Pozzi forceps)

Primary outcome

Patient-reported pain: Visual Analogic Scale
Time frame: Before the procedure
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.
Patient-reported pain: Visual Analogic Scale
Time frame: During speculum insertion
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.
Patient-reported pain: Visual Analogic Scale
Time frame: During AspivixTM / standard tenaculum application
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.
Patient-reported pain: Visual Analogic Scale
Time frame: During application of cervical traction
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.
Patient-reported pain: Visual Analogic Scale
Time frame: During IUD insertion
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.
Patient-reported pain: Visual Analogic Scale
Time frame: During AspivixTM / standard tenaculum release
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.
Patient-reported pain: Visual Analogic Scale
Time frame: 5 minutes after the end of the procedure
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.

7 secondary outcomes

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
Time frame: 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
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 15 Feb 2022.

Related trials for IUD Insertion

Recruiting
Effect of Periumbilical Vibration on Pain Perception During Intrauterine Device Insertion: A Randomized Controlled Trial
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LI4 Acupuncture for Pain During Intrauterine Device Insertion
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Recruiting
Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years.
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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Traction of the cervix for IUD insertion in people with IUD Insertion, run by Aspivix SA at 2 sites 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 20 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Patient-reported pain: Visual Analogic Scale (time frame: Before the procedure). The study lists 7 primary outcomes in all. 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 NCT04441281.

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 15 Feb 2022.