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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver and Kidney Tumours

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RF electrodes can be accurately and safely placed in the desired location

Outcome Description:

this will be assessed during the surgery and once the tumour is removed and examined

Outcome Time Frame:

up to 10 days prior to surgery and up to 24 hrs after surgery

Safety Issue:

Yes

Principal Investigator

Michael Jewett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Research Ethics Committee

Study ID:

RFA

NCT ID:

NCT01720706

Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Liver and Kidney Tumours
  • Liver tumour
  • Kidney tumour
  • Hepatectomy
  • Nephrectomy
  • Metastatic Colon Cancer
  • Renal Cell Carcinoma
  • Kidney Neoplasms

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