Clinical trial · Interventional
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
NCT04230642CI-TRIAL-00049860completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
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 |
|---|---|---|---|
| Hepatic Tumor | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The Quantum Surgical device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic device
- description
- Needle placement to the tumor, one time, the day of the ablation procedure
- interventionNames
- Device: The Quantum Surgical device
Primary outcomes (2)
- measure
- Evaluation of the safety related to the procedure
- timeFrame
- During the procedure
- description
- Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
- measure
- Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
- timeFrame
- During the procedure
- description
- Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: * Patient is at least 18 years old, * Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians, * Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP \> 50%), * Patient who agrees to participate in the evaluation and who has signed the inform consent, * Patient covered by social security system. Exclusion Criteria: * Patient unable to undergo general anesthesia, * Patient unable to tolerate CT contrast agent * Patient already participating in another clinical study * Pregnant or breast-feeding woman.
References
Publications (0)
Data not yet available
No reference posted for this study.