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New ultrasound dye could stop unnecessary emergency surgeries for ovarian torsion

NCT ID NCT06677554

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a contrast dye to standard ultrasound can better diagnose adnexal torsion (twisted ovary) and reduce unnecessary emergency surgeries. Currently, about 3 in 10 women who have emergency surgery for suspected torsion do not actually have it. The trial will involve 256 women with strong suspicion of torsion, comparing standard care to standard care plus contrast-enhanced ultrasound. If successful, this could spare many women from unnecessary surgery and its risks.

What this could mean

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

Active substance
SonoVue® (contrast agent for ultrasound)
What this could lead to
If successful, this could provide a reliable, non-surgical way to diagnose adnexal torsion, reducing unnecessary emergency surgeries and preserving fertility.
What could go wrong
This is a Phase 3 trial, but the technique is still being tested against standard care. The contrast agent may cause allergic reactions, and the results may not apply to all patients or settings.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 256 people

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

Started

May 2025

Expected to finish

Feb 2028

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: * Age 18 or over * Person who has carried out a preliminary clinical examination adapted to the clinical trial * Strong suspicion of adnexal torsion with surgery planned * No ongoing pregnancy or breastfeeding * Affiliation to or beneficiary of a social security scheme * Person who has received complete information on the organization of the research and has signed their informed consent Exclusion Criteria: * Person who does not understand and/or speak French * Any medical situation that does not indicate the administration of SonoVue®, including: * Known hypersensitivity to sulphur hexafluoride or any of the other components of SonoVue * Woman with acute coronary syndrome or unstable ischemic heart disease * Woman with acute endocarditis * Woman with valve prostheses * Women with acute systemic inflammatory disease and/or sepsis * Woman with hypercoagulation and/or recent thromboembolic accident * End-stage woman with kidney or liver disease * Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure \> 90 mmHg) * Women with uncontrolled systemic hypertension * Woman with respiratory distress syndrome * Medical condition contraindicating the administration of SonoVue®, * History of PEG allergy (or macrogol) * Person referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014: * Pregnant, parturient or breastfeeding/nursing mother * Minor (not emancipated) * Adult subject to a legal protection measure (guardianship, curatorship, safeguarding of justice) * Person of legal age who is unable to express consent

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Conditions

The condition(s) this trial relates to.

Ovarian Torsion

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 sites. 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

  • CHRU Nancy - Maternité Régionale

    RECRUITING

    Nancy, France

  • CHU

    NOT_YET_RECRUITING

    Besançon, France

  • CHU

    NOT_YET_RECRUITING

    Dijon, France

  • CHU

    NOT_YET_RECRUITING

    Reims, France

  • CHU Hautepierre

    NOT_YET_RECRUITING

    Strasbourg, France

  • CMCO

    NOT_YET_RECRUITING

    Schiltigheim, France

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