Study on the Use of Sulfur Hexafluoride in Ultrasound for Diagnosing Adnexal Torsion in Patients with Suspected Ovarian Twisting

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What is this study about?

This clinical trial is focused on studying a condition known as adnexal torsion, which occurs when an ovary or fallopian tube twists, potentially cutting off its blood supply. The study will use a special imaging technique called contrast enhanced ultrasound to help diagnose this condition. The contrast agent used in this study is called SonoVue, which contains a substance known as sulfur hexafluoride. This agent is injected into the bloodstream to improve the clarity of ultrasound images.

The purpose of the study is to evaluate whether using contrast enhanced ultrasound can improve the accuracy of diagnosing adnexal torsion compared to the standard method, which does not use contrast. Participants in the study will be randomly assigned to one of two groups: one group will receive the contrast enhanced ultrasound, and the other will undergo the standard diagnostic procedure. The study aims to determine if the new method can reduce unnecessary surgeries by providing clearer diagnostic information.

Throughout the study, participants will be monitored for any immediate or delayed reactions to the contrast agent, as well as for any complications related to the condition or its treatment. The study will also track the rate of hospitalizations, consultations, and any additional surgeries needed within a month after the initial diagnosis. The goal is to gather data that could help improve the diagnostic process for adnexal torsion and potentially lead to better outcomes for patients experiencing this condition.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose and procedures. You will need to confirm your understanding and agreement to participate by signing a consent form.

2 initial assessment

An initial clinical examination will be conducted to confirm a strong suspicion of adnexal torsion. This is a condition where the ovary or other adnexal structures twist, potentially cutting off blood supply.

3 contrast ultrasound procedure

If you meet the criteria, you will undergo a contrast-enhanced ultrasound. This involves the administration of a contrast agent called SonoVue, which contains sulfur hexafluoride. The contrast agent is given through an intravenous infusion to help improve the ultrasound images.

4 monitoring and evaluation

After the ultrasound, you will be monitored for any immediate reactions to the contrast agent. This includes checking for any serious adverse events within 30 minutes of the injection and any delayed hypersensitivity reactions.

5 surgery decision

Based on the ultrasound results, a decision will be made regarding the necessity of emergency surgery. The goal is to avoid unnecessary surgery if adnexal torsion is not confirmed.

6 follow-up

You will have follow-up consultations to assess your recovery and any potential complications. This includes evaluating pain levels at 7 days and checking for any complications at 1 month, such as infection or the need for additional surgery.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have had a preliminary clinical examination suitable for the clinical trial.
  • Must have a strong suspicion of adnexal torsion with surgery planned. Adnexal torsion refers to the twisting of the ovary and sometimes the fallopian tube, which can cause severe pain and other symptoms.
  • Must not be pregnant or breastfeeding.
  • Must be affiliated with or a beneficiary of a social security scheme.
  • Must have received complete information about the organization of the trial.

Who Cannot Join the Study?

  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Cvfqvx Hycvjjdcmms Uepphfbqlyigz Rziuo Reims France
Clbkng Hvmtxqabgdf Udmumncnvkivw Dr Dhrlg Dijon France
Bmwifigv Uengnihrsv Hhivdvsp Cocogv Besançon France
Cmru Dk Nukcz Vandoeuvre Les Nancy France
Hecsnqxv Udofdbyksxhsew Svwugeafiv &xpmpan Hixkglb dq Hheljsxbwfg STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
14.10.2024

Trial locations

Investigated drugs:

The provided data does not include specific medications or therapies involved in the clinical trial. The trial focuses on evaluating a diagnostic strategy using contrast-enhanced ultrasound for diagnosing adnexal torsion. Since no medications or therapies are listed, there are no descriptions to provide.

Adnexal torsion – Adnexal torsion is a condition where the ovary and sometimes the fallopian tube twist around the tissues that support them. This twisting can cut off the blood supply to these organs, leading to severe pain and potential damage. The condition often presents with sudden onset of lower abdominal pain, nausea, and vomiting. As the torsion progresses, the lack of blood flow can cause the affected ovary to swell and become necrotic. If left unresolved, it can lead to complications such as infection or loss of the ovary. The condition requires prompt medical attention to prevent further complications.

Trial ID:
2024-511720-13-00
Protocol code:
2021PI162
Trial Phase:
Therapeutic confirmatory (Phase III)

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