Radiofrequency ablation (RFA)
DeviceMinimally invasive RFA in T1a renal carcinomas
Other names: Next-generation Radiofrequency Generator (Cambridge Interventional)
NCT Number: NCT07465458
This observational study is designed to expand the current database available in the literature and the existing knowledge on the outcomes and safety of radiofrequency ablation (RFA) for the treatment of primary renal cell carcinomas in stage T1a. All interventions and subsequent follow-ups are clinical decisions are independent of the study, given its observational nature.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
IRCCS Ospedale San Raffaele, Milan, Milano, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient selection criteria will be those typically established by each participating center t with T1a primary renal tumors for which a Multidisciplinary Tumor Board has indicated as candidates for treatment with radiofrequency ablation.I
Inclusion criteria
Exclusion criteria
Minimally invasive RFA in T1a renal carcinomas
Other names: Next-generation Radiofrequency Generator (Cambridge Interventional)
Time frame: up to 2 months post-procedure
ablation zone evaluated post-ablation
Time frame: up to 12 months
Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging
Time frame: up to 12 months
complications and adverse events
Time frame: up to 12 months
Evaluate RFA procedural success based on the TRIFECA benchmark standards
Time frame: up to 12 months
RFA outcome according to histological subtype
Time frame: up to 12 months
evaluate the number of patients who develop local recurrence or residual tumor growth after ablation
Time frame: up to 12 months
evaluate the number of patients who develop distant metastasis after ablation
Time frame: up to 12 months
Time from RFA to death for any cause
Time frame: up to 12 months
Time from RFA to renal cell carcinoma (RCC)-related death
Time frame: up to 12 months
evaluate the impact of RFA on renal function
Time frame: up to 12 months
number of participants requiring additional RFA
Time frame: up to 12 months
time in months from initial RFA to first detection of local tumor on imaging
Time frame: up to 12 months
Pain and quality of life questionaires (QOL) - European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (higher score worst outcome
Time frame: up to 12 months
compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates.
Contact information is provided by the study sponsor or research team.
Humanitas Hospital, Italy
Other
Acronym: RASROP-003
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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