Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
NCT ID: NCT06590532
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2024-12-10
2026-05-01
Brief Summary
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The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). This will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available
Detailed Description
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The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included.
Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fusion group
patient undergoing endovascular aortic repair with fusion imaging system guidance
Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.
Control group
patient undergoing endovascular aortic repair without fusion imaging system guidance (only with X-rays and roadmaping)
Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)
Interventions
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Endovascular aneurysm repair or aorto iliac endovascular revascularisation with Fusion imaging system Cydar-EV
Cydar-EV image fusion is a CE-marked medical device, which instead of a table-tacked overlay uses computer vision to fuse pre-procedural 3D images with intra-operative 2D fluoroscopy automatically and in real-time.
Endovascular aneurysm repair or aorto iliac endovascular revascularisation without Fusion imaging system Cydar-EV
patients will be assigned either to an endovascular repair using standard X-ray fluoroscopy imaging alone (the current reference standard)
Eligibility Criteria
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Inclusion Criteria
* Surgeon trained in the use of image fusion
* Operator who has given their consent
* Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft
* Patient in possession of an angioscan less than 6 months old
* Patient of legal age who has given his/her consent
* Ionising radiation generator with up-to-date and validated quality control
* Participant affiliated to a Social Security scheme
Exclusion Criteria
* Procedure performed without an operating aid.
* Emergency procedure.
* Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch).
digestive arteries, iliac branch).
* Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft)
* Aortic emergencies (ruptured AAA).
* Persons under guardianship, curatorship or safeguard of justice
* Pregnant or breast-feeding women.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Rinckenbach
Besançon, Besançon, France
NASR
Brest, Brest, France
El Batti
Créteil, Créteil, France
Spear
Grenoble, Grenoble, France
Pr Blandine Maurel
Nantes, Nantes, France
Jean-Baptiste
Nice, Nice, France
Duprey
Reims, Reims, France
Countries
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Central Contacts
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Facility Contacts
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Simon Rinckenbach, Pr
Role: primary
Simon Rinckenbach, Pr
Role: backup
Bahaa Nasr, Pr
Role: primary
Bahaa Nasr, Pr
Role: backup
Salma El Batti, Pr
Role: primary
Salma El Batti, Pr
Role: backup
Rafaëlle Spear, Pr
Role: primary
Rafaëlle Spear, Pr
Role: backup
Blandine Maurel, Pr
Role: primary
Blandine MAUREL, Pr
Role: backup
Elixène Jean-Baptiste, Pr
Role: primary
Elixène Jean-Baptiste, Pr
Role: backup
Ambroise Duprey, Pr
Role: primary
Ambroise Duprey, Pr
Role: backup
Other Identifiers
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RC22_0396
Identifier Type: -
Identifier Source: org_study_id