Value of contrast-enhanced ultrasound for diagnosis of ovarian torsio

Phase 1

• Conditions: Adnexal torsion; MedDRA version: 20.0Level: LLTClassification code 10044069Term: Torsion of ovarySystem Organ Class: 100000004872; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2020-000993-27-FR
• Lead Sponsor: CHRU NANCY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-25
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Age = 18 years
Planned surgery for suspected adnexal torsion
Being affiliated to the Social Security system or benefiting from such a system
Have received full information about the organization of the study and have signed their informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Any medical condition that contraindicates the administration of SonoVue® , in particular :
o Documented hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue
o Woman with acute coronary syndrome or unstable ischemic heart disease
o Woman with acute endocarditis
o Woman with prosthetic valves
o Woman with acute systemic inflammatory disease and/or sepsis
o Woman in a state of hypercoagulation and/or recent thromboembolic event
o Woman with end-stage kidney or liver disease
o Woman with right-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure > 90 mmHg)
o Woman with uncontrolled systemic hypertension
o Woman with respiratory distress syndrome
Persons referred in Articles L. 1121-5, L. 1121-7 and L1121-8 of French Public Health Code :
o Pregnant woman, parturient or breastfeeding mother
o Minor person (not emancipated)
o Adult person under legal protection (guardianship, curatorship, legal safeguard)
o Adult who is unable to give consent
Persons who are deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified