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RECRUITING
NCT05465161
NA

STING MARK Universal Fiducial Marker System

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

Summary

Currently available fiducial marker and fiducial insertion strategies are rudimentary, imprecise, not compatible with multiple insertion catheters/needles and are overall unreliable. STING-MARK device is the first universal, fully detachable and non-premounted radiopaque fiducial device system. Allowing biopsy prior to insertion, STING-MARK is easily and reliably delivered through-the-needle to the tumor, in order to accurately pinpoint its location for image-guided therapies. This study aims at establishing proof of concept for STING-MARK, by demonstrating its usability, reproducibility, radio-opacity and retention in a variety of clinically-relevant ex vivo organ samples.

Official title: An Ex-Vivo Human Model Study for Proof of Concept, Usability, Reproducibility, Radio-Opacity and Marker Retention

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-02-28

Completion Date

2025-11-01

Last Updated

2024-12-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Sting Mark Fiducial Marker

Device insertion will occur with the designated needles and through the appropriate organ-specific route and imaging guidance. Multiple STING-MARK fiducials will be inserted. Plain film x-rays in 3 planes of the organs with the marker inserted will be taken and recorded.

Locations (1)

CHUM

Montreal, Quebec, Canada