COVARIAN : Contribution of contrast enhanced ultrasound for diagnosis of adnexal torsion

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHRU De Nancy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

14 May 2025 → ongoing

Decision date (initial)

2024-10-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

This study is funded by the French DGOS as part of the Interregional PHRC 2022

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Diagnosis, Efficacy

To evaluate a two-stage diagnostic strategy including the contrast evaluation of ultrasound compared to the standard diagnostic strategy (without contrast evaluation of ultrasound) in case of strong suspicion of adnexal torsion on performing wrongly surgery, defined by performing emergency surgery (within 6 hours) without proven torsion.
A strong suspicion of adnexal torsion is defined when there is a diagnostic doubt after standard assessment or when surgery is considered.

Secondary objectives 4

1. To compare the effectiveness of the strategy including contrast ultrasound versus the standard strategy in patients without initial surgical management on: - The rate of hospitalizations in the month following the initial consultation, - The rate of consultations in the month following the initial consultation, - Pain level at 7 days after initial consultation, - The rate of secondary surgery with confirmed torsion in the month following the initial consultation, - The rate of complications that may be related to a delay in the management of a proven torsion (pelvic abscess, pelviperitonitis, necrotic aspect of the ovary, non conservative treatment) in the month following the initial consultation.
2. To compare the effectiveness of the strategy including contrast ultrasound versus the standard strategy in patients with initial surgical management on: - The duration of hospitalization, - Per and post-operative complications, - The rate of hospitalizations and consultations in the month following the initial consultation, - Pain level at 7 days.
3. To assess the safety of administering SonoVue® in patients with high suspicion of adnexal torsion (only for the experimental group).
4. To evaluate the process related to the diagnostic procedure under study: acceptability by all relevant stakeholders and feasibility of the procedure by gynecologists-obstetricians. If the strategy including contrast ultrasound is demonstrated to be effective, the process evaluation will support the transferability of the strategy for its large-scale deployment.

Conditions and MedDRA coding

adnexal torsion

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - 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

Exclusion criteria 1

1. - Non-French-speaking person - Any medical situation that does not indicate the administration of SonoVue®, including: o Known hypersensitivity to sulphur 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 valve prostheses o Women with acute systemic inflammatory disease and/or sepsis o Woman with hypercoagulation and/or recent thromboembolic accident o End-stage woman with kidney or liver disease o Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg) o Women with uncontrolled systemic hypertension o Woman with respiratory distress syndrome o 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of surgical procedures performed in emergency (within 6 hours of arrival of the patient) without proven torsion (no visible spiral turn in intraoperative) in each group.

Secondary endpoints 4

1. To meet secondary objective #1: Rate of hospitalization and rate of consultation at 1 month, pain at 7 days evaluated by a numerical scale, rate of secondary surgery with proven torsion at 1 month, rate of complications (pelvic abscess, pelviperitonitis, necrotic aspect of the ovary, non conservative treatment) at 1 month.
2. To meet secondary objective #2: -Length of hospitalization expressed in hours or days, -Collection of intraoperative complications (during hospitalization): hemorrhage, vascular wound, digestive wound, -Collection of postoperative complications at 1 month: secondary hemorrhage, surgical resumption (whatever the reason), scar disunity, scar abscess, -Hospitalization rate and consultation rate at 1 month, -7-day pain assessed by numerical scale.
3. To meet secondary objective #3: Incidence of serious adverse events within 30 minutes of injection of SonoVue® and collection of any delayed hypersensitivity manifestations (skin, respiratory).
4. To meet secondary objective #4:Quantitative and qualitative data from the process evaluation will be compared to identify and remove potential obstacles to the use of contrast ultrasound in cases of suspected adnexal torsion.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHRU De Nancy

Sponsor organisation

CHRU De Nancy

Address

Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Bp 60034 29 Avenue Du Mal De Lattre De Tassigny Bp 60034

City

Nancy Cedex

Postcode

54035

Country

France

Scientific contact point

Organisation

CHRU De Nancy

Contact name

Dr Charline BERTHOLDT

Public contact point

Organisation

CHRU De Nancy

Contact name

Dr Charline BERTHOLDT

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications