NCT07021573

Protoporphyrin Imaging in Multispectral Evaluation of Resections

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.

Detailed description

The clinical study is conducted in the post-market stage according to ISO 14155 Annex I.1 as it is performed with a CE marked microscope system. An additional component (CALLAO) will be added to the microscope. The intended use of the microscope as well as the surgical procedure remain unchanged by this addition. CALLAO allows for taking pictures of the situs in the OR which increases the surgery duration by \<1min per picture. Therefore, this is a non-interventional study with a minimal burden to subjects. The clinical investigation is not for a conformity assessment purpose. The burden to subjects is non-interventional.

Conditions

• Glioma

Interventions

Type	Name	Description
DEVICE	KINEVO 900 S with BLUE 400	The investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras.

Timeline

• Start date: 2025-09-30
• Primary completion: 2025-12-31
• Completion: 2026-05-01
• First posted: 2025-06-15
• Last updated: 2025-09-09

Locations

10 sites across 3 countries: Austria, Germany, Switzerland