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New treatment option for Adnexal Torsion
Official title Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion
ClinicalTrials.gov ID: NCT06677554
What this study is testing
What is Addition of ultrasound with contrast injection (SonoVue®)?
Addition of ultrasound with contrast injection (SonoVue®) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for adnexal torsion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Dijon, France
- Nancy, France
- Reims, France
- Schiltigheim, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Dijon, France; Nancy, France; Reims, France; Schiltigheim, France; Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.