New ultrasound dye could stop unnecessary emergency surgeries for ovarian torsion
NCT ID NCT06677554
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 256 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHRU Nancy - Maternité Régionale
RECRUITINGNancy, France
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CHU
NOT_YET_RECRUITINGBesançon, France
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CHU
NOT_YET_RECRUITINGDijon, France
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CHU
NOT_YET_RECRUITINGReims, France
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CHU Hautepierre
NOT_YET_RECRUITINGStrasbourg, France
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CMCO
NOT_YET_RECRUITINGSchiltigheim, France
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