Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice

Launched by NANTES UNIVERSITY HOSPITAL · Sep 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of an advanced mobile hybrid room for vascular surgery, specifically for patients with certain types of artery diseases. The goal is to see if this new technology, which includes an automated imaging system, can make surgeries faster and safer while also reducing costs and the amount of radiation exposure for both patients and medical staff. By comparing this mobile setup to traditional surgery methods, the researchers hope to find out if it leads to better outcomes for patients.

To participate in this trial, individuals must be adults who have certain health conditions related to artery issues and have had a recent medical scan. Participants will need to be treated in a specific type of operating room and will be required to provide consent for the procedure. This study is currently recruiting patients, and it’s important to note that those with certain complications or emergencies, as well as pregnant or breastfeeding women, will not be eligible. Overall, participants can expect to contribute to important research that could improve future surgical practices.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.