Clinical trial · Interventional
Thermal Ablation in Larger Liver and Kidney Tumours
Thermal Ablation With a Loosely Wound Helical Coil for Radiofrequency Treatment of Large Renal and Hepatic Tumors in Patients Undergoing Partial or Total Nephrectomy or Heptectomy
- 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 is a clinical research study designed to determine the safety and efficacy of the application of a unique interstitial radio frequency thermal therapy for the treatment of large tumours in the kidney or liver. The novel device offers patients a more effective therapy than conventional RFA and for patients with large tumours fewer number of treatments and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will be determined by a combination of biopsy and contrast enhanced CT imaging. The study will assess if novel device can produce lesions in the liver or kidney in a controlled and predictable manner and with sufficient size to effectively manage disease progression in the organ. The extent of lesion size at a delivered power setting and treatment time will be measured with post-treatment CT or MRI and biopsy as measures of tissue response
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 |
|---|---|---|---|
| Liver and Kidney Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA Loosely wound thermal coil | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acute
- description
- The RFA Loosely wound thermal coil electrode will be inserted directly or percutaneously into the lesion, depending on the imaging modality (US or CT guidance) and deployed with same method as previously described in the 'delayed group'. Energy will be delivered using the single timed heating cycle. Treatment will be monitored with B mode US. Once the cycle is completed, the probe will be removed and the planned surgery will continue with partial or radical nephrectomy.
- interventionNames
- Device: RFA Loosely wound thermal coil
- type
- EXPERIMENTAL
- label
- Delayed
- description
- Using an electrically insulated 12ga introducer with trocar is inserted percutaneously into the renal tumor. The needle tip will be placed 20mm from the center of the target. The trocar is removed and co-axially (i.e. within the introducer), a core biopsy of the lesion is performed with a 14-18 gauge needle. The radiofrequency applicator with a 14ga cannula containing the RFA Loosely wound thermal coil electrode is then optimally positioned and locked into the introducer. On approximately day 6-10, a partial or radical nephrectomy will be performed in the usual way.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * subjects with a solid renal mass who are undergoing partial or radical nephrectomy * subjects with a solid hepatic masses of heptacellular carcinoma or metastatic liver tumour booked for partial or radical hepatectomy Exclusion Criteria: * irreversible coagulation defects, * hepatic infection, * no extra hepatic malignant disease, * venous invasion and/or * morbid obesity
References
Publications (0)
Data not yet available