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Compares treatment options for Endovascular
Official title Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice
ClinicalTrials.gov ID: NCT06590532
What this study is testing
- What it's testing
- Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a French multicentre clinical setting. 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).
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with...
- 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
You likely can't join if
- First procedure with fusion for the previously trained surgeon.
- 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).
See the full eligibility criteria
- Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available
- 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
- First procedure with fusion for the previously trained surgeon.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, Besançon, France
- Brest, Brest, France
- Créteil, Créteil, France
- Grenoble, Grenoble, France
- Nantes, Nantes, France
- Nice, Nice, France
- Reims, Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, Besançon, France; Brest, Brest, France; Créteil, Créteil, France; Grenoble, Grenoble, France; Nantes, Nantes, France; Nice, Nice, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.