FORS FIRST

First-in-Human Study for Fiber Optic RealShape (FORS)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28817

Enrollment

Registered

2018-06-14

Start date

2018-07-15

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abdominal aortic aneurysm (AAA), iliac aneurysms (IA), stenotic lesions of the iliac artery or Superficial Femoral Artery (SFA).

Interventions

-aortic endovascular intervention -peripheral endovascular intervention

Eligibility

Inclusion criteria

Inclusion criteria: -Age > 18 years -Willingness to sign the informed consent -Scheduled for elective endovascular procedure either for stenotic or aneurysmatic pathology -Anatomical conformation suitable for the investigational medical devices (5.5 F 80cm Cobra C2 catheter, and/or 5.5F 80cm Berenstein catheter, and a 0.035” 120cm floppy guidewire)

Exclusion criteria

Exclusion criteria: -Intolerance to contrast media -Emergency procedure -Current participation in a concurrent trial that may confound study results -Subjects unwilling or unable to comply with the protocol -Subjects unable to understand verbal and/or written informed consent

Design outcomes

Primary

Measure	Time frame
Technical success of navigation	—

Secondary

Measure	Time frame
-Procedural technical success (defined as successful completion of the procedure) -Type of procedure -Cumulative Air Kerma (AK) -Cumulative Dose Air Product (DAP) -Cumulative Digital Subtraction Angiography (DSA) dose -Cumulative fluoroscopy dose -Cumulative fluoroscopy time -Cumulative contrast agent volume -Cumulative staff dose for each staff member (operator 1, operator 2, sterile nurse) -Radiation dose XperCT, if applicable -“Skin-to-skin” procedure time -Time to perform each navigation task -AK of each navigation task -DAP of each navigation task -Fluoroscopy time of each navigation task -Staff dose of each staff member for each navigation task (operator 1, operator 2, sterile nurse) -Number of re-registrations of CTA -Number of re-registrations of FORS-enabled device visualization -Number of bail outs (switch to X ray-guidance only) during navigation tasks and reason for it -Type of treatment device (type, brand) -Serious Adverse Device Effects (SADEs)	—

Measure

Time frame

-Procedural technical success (defined as successful completion of the procedure) -Type of procedure -Cumulative Air Kerma (AK) -Cumulative Dose Air Product (DAP) -Cumulative Digital Subtraction Angiography (DSA) dose -Cumulative fluoroscopy dose -Cumulative fluoroscopy time -Cumulative contrast agent volume -Cumulative staff dose for each staff member (operator 1, operator 2, sterile nurse) -Radiation dose XperCT, if applicable -“Skin-to-skin” procedure time -Time to perform each navigation task -AK of each navigation task -DAP of each navigation task -Fluoroscopy time of each navigation task -Staff dose of each staff member for each navigation task (operator 1, operator 2, sterile nurse) -Number of re-registrations of CTA -Number of re-registrations of FORS-enabled device visualization -Number of bail outs (switch to X ray-guidance only) during navigation tasks and reason for it -Type of treatment device (type, brand) -Serious Adverse Device Effects (SADEs)

—

Contacts

Public ContactJ.A. Herwaarden, van

UMC Utrecht

j.a.vanherwaarden@umcutrecht.nl0887556965

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)