The efficacy and safety of Irreversible Electroporation for the ablation of Small Renal Masses: A prospective in-vivo pilot study

The efficacy and safety of Irreversible Electroporation for the ablation of Small Renal Masses: A prospective in-vivo pilot study - Efficacy and Safety of IRE for SRMs.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46982

Enrollment

Registered

2016-05-09

Start date

2016-07-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cancer Renal Cell Carcinoma

Interventions

Patients will receive IRE ablation of the SRM, performed under general anaesthesia. Follow-up will be performed using CT, MRI, and CEUS at 1 week, 3 months, 6 months, and 1 year post IRE.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age * 18 years - Solid, enhancing mass on cross sectional imaging - Signed informed consent - Candidate for focal ablative therapy

Exclusion criteria

Exclusion criteria: - Irreversible bleeding disorders - Anaesthesia Surgical Assignment (ASA), category * IV - ICD / pacemaker - Severe cardiovascular disease in medical history

Design outcomes

Primary

Measure	Time frame
Primary study parameter: - Clinical efficacy of IRE ablation of small renal masses (* 4cm), assessed by calculating recurrence and residual disease at follow-up, measured through the (non-) presence of tumour enhancement on cross-sectional imaging post IRE	—

Secondary

Measure	Time frame
Secondary study parameters: - Safety of IRE ablation of small renal masses (* 4cm), by evaluating device and procedural adverse events using CTCAE v4.0 - CT, MRI and CEUS in the imaging of ablation success, extend of the ablation zone, 1 week, 3 months, 6 months, and 1 year post IRE - Peri-operative outcomes after IRE ablation of small renal masses (* 4cm), such as renal function, measured by creatinine levels and eGFR pre- and post-operative, proteinuria, average length of hospital stay, average operation time, and pain level after IRE, measured by VAS and analgesics use	—

Measure

Time frame

Secondary study parameters: - Safety of IRE ablation of small renal masses (* 4cm), by evaluating device and procedural adverse events using CTCAE v4.0 - CT, MRI and CEUS in the imaging of ablation success, extend of the ablation zone, 1 week, 3 months, 6 months, and 1 year post IRE - Peri-operative outcomes after IRE ablation of small renal masses (* 4cm), such as renal function, measured by creatinine levels and eGFR pre- and post-operative, proteinuria, average length of hospital stay, average operation time, and pain level after IRE, measured by VAS and analgesics use

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)