Clinical Performance Study of the ABTest Card® Device.

NCT ID: NCT06557031

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-01-31

Brief Summary

The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.

Detailed Description

Following some changes in the ABTest Card® raw materials, a new validation of the associated clinical performances is required. Raw materials of the ABTest Card® are : Triton, Cleanis, Tween, Yellow, Blue dye and the blood segment opener device.

According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council", 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").

The Regulation 2017/746 (IVDR) on IVDMD, has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the ABTest Card® is already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.

The purpose of this study is to document and verify the clinical performance of the ABTest Card® device in combination with the new raw materials used for manufacturing (ABTest Card®NEW), by comparing the results obtained with the ABTest Card®REF, already commercialised and used routinely by the study sites.

Conditions

Transfusion Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

ABTest Card®REF and ABTest Card®NEW

Pre transfusional control with the ABTest Card®REF device (predicate device) and the ABTest Card®NEW device (investigational device).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old for the category marked with *.
• Undergo capillary blood sampling ;
• Belong to one of the clinical categories:
• Patient in need of blood transfusion without any pathology known to have an impact on transfusion act* ;
• Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)* ;
• Patient in need of blood transfusion suffering from haematology disease (e.g. cancer), or undergoing haemodialysis* ;
• Patient with cold agglutinin* ;
• Premature patient with gestational age < 37 weeks or newborn ≤27 days old in need of blood transfusion ;
• Newborn eligible for the Guthrie Test ;
• Newborn eligible for the glycaemic test.
• Have health care insurance ;
• Have given his/her written consent (or legal representative in the case of a newborn) ;

Exclusion Criteria

• Pregnant woman ;
• Person deprived of liberty ;
• Unconscious person ;
• Person under guardianship or trusteeship ;
• For paediatric clinical category: age ≥28 days and <18 years old.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soladis

INDUSTRY

Sponsor Role: collaborator

Diagast

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Orléans

Orléans, , France

Countries

France

Central Contacts

Céline BOURIEZ

Role: CONTACT

regulatory@diagast.com

+33 (0) 3.20.96.53.86

Facility Contacts

Silvana LEO-KODELI

Role: primary

Other Identifiers

CPSP_23-03

Identifier Type: -

Identifier Source: org_study_id