A Safe Framework for Quantitative In Vivo Human Evaluation of Image Guidance

Area of Science:

• Medical technology
• Surgical robotics
• Image-guided therapy

Background:

• Evaluating image guidance systems (IGS) in vivo is crucial for surgical advancement.
• Current evaluation methods may pose risks to patient care.
• A safe and effective evaluation framework is needed for developing IGS.

Purpose of the Study:

• To introduce a novel framework, the "bystander protocol," for in vivo evaluation of image guidance systems.
• To demonstrate the protocol's application in robotic partial nephrectomy.
• To assess the safety and efficacy of the bystander protocol.

Main Methods:

• The bystander protocol employs two surgeons: one performing the procedure and one evaluating the IGS.
• This separation isolates therapy from evaluation, minimizing risks to the standard of care.
• The protocol was applied in a case study during 6 robotic partial nephrectomy surgeries.

Main Results:

• The bystander protocol was successfully implemented in 6 patient cases.
• The in vivo lesion centroid localization error for the IGS was measured at 6.5 mm.
• This contrasts with a prior phantom result of 3.0 mm, highlighting in vivo challenges.

Conclusions:

• The bystander protocol provides a safe and effective method for testing novel image guidance systems.
• This framework facilitates the evaluation of IGS in human subjects without compromising patient safety.
• The protocol enables rigorous assessment of IGS performance in real-world clinical settings.