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Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion

RecruitingPhase 3Ages 18 Years - anyFemaleCentral Hospital, Nancy, France
NCT06677554 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Adnexal torsion is the rotation of the ovary around its vascular axis resulting, in the absence of treatment, ischemia that can lead to peritonitis by necrosis or impaired fertility. It is a gynecological emergency affecting 3% of women of childbearing age, including from adolescence, and requires surgical treatment as soon as possible, classically within 6 hours. The symptomatology of adnexal torsion is dominated by pelvic pain of sudden onset and variable intensity, an aspecific sign that does not allow a diagnosis of certainty. There are no biological markers and, in the context of the emergency, the only imaging examination available is pelvic ultrasound associated with a Doppler flow analysis but with a low and variable diagnostic performance depending on the studies (sensitivity variable from 46 to 73%). There are currently no tests that can provide a diagnosis of certainty. Only

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📋 Eligibility rules (as published)
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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What it tests

  • Addition of ultrasound with contrast injection (SonoVue®)
  • Standard Care (in control arm)
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Where

6 sites
CHU
Besançon, France
CHU
Dijon, France
CHRU Nancy - Maternité Régionale
Nancy, France
CHU
Reims, France
CMCO
Schiltigheim, France
CHU Hautepierre
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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