Clinical trial · Interventional
STING MARK Universal Fiducial Marker System
An Ex-Vivo Human Model Study for Proof of Concept, Usability, Reproducibility, Radio-Opacity and Marker Retention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sting Mark Fiducial Marker | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- StingMark Fiducial Marker
- description
- 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.
- interventionNames
- Device: Sting Mark Fiducial Marker
Primary outcomes (3)
- measure
- Gain experience with deployability of the device in multiple organs, through different needles and different routes of insertion (trans-cutaneous, endoscopic).
- timeFrame
- Through study completion, an average of 1 year
- description
- 1\) The deployability of the device will be measured with a deployability performance score (3=best over all metrics, 9=worst over all metrics) and compared with that of competing devices (Ultra EchoTip, Lumicoil) tested in parallel by the same user(s). No health outcomes are used in this score. Metrics used to establish this score are : operational efficiency ratio (the number of occurences of proper travel/anchoring/detaching over the total number of trials), time of operation and number of steps (from the first handling of the device to its detachment or lack thereof). Tests will be conducted on different organ locations (lung, oseophagus) with different routes of insertion (trans-cutaneous, endoscopic) using different models of 22Ga biopsy needles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing surgical resection of solid organs * Recipients of solid organ transplantation Exclusion Criteria: * None
References
Publications (0)
Data not yet available