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New suction device aims to ease IUD insertion pain

NCT ID NCT07290517

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study compares a new suction-based cervical stabilizer (Carevix) to the standard metal clamp (tenaculum) for IUD insertions. 100 women will be randomly assigned to one device, and they will rate their pain on a 0-10 scale. The goal is to see if the gentler suction tool causes less discomfort during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Carevix suction-based cervical stabilizer device
What this could lead to
If it works, this could offer a less painful IUD insertion experience for women, especially those who have not given birth.
What could go wrong
This is a small, early-stage trial with only 100 participants, so results may not apply to everyone. The device is already FDA-approved, but pain reduction may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (to be assessed prior to procedure): * Age 18 years or older * Able to consent on their own * Scheduled and will undergo an IUD insertion within 90 days of consent * Planned use of cervical stabilization device for placement * Procedure being performed by a trained provider * Provider is willing to use Carevix™ for scheduled procedure Exclusion Criteria (to be assessed by provider at time of procedure): * Vaginal bleeding of unknown origin * Cervix less than 26 mm in diameter * Nabothian cyst on anterior lip of cervix * Cervical myomas * Cervical abnormalities/shape * Pregnant * Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language * Other inability to provide informed consent to participate * Initial attempt to place the IUD without any cervical stabilization

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Conditions

The condition(s) this trial relates to.

Metrorrhagia Neck Pain Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abnormal uterine bleeding IUD Pain, cervical

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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