NCT02370342

Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery

Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) for Thermal Ablative Therapy of Small Renal Mass: Corroborating With Robot-Assisted Laparoscopic Partial Nephrectomy Specimens

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies a type of ultrasound called robot-assisted laparoscopic high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave therapy, in treating patients with small kidney masses undergoing partial removal of the kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors locate the mass. The probe then uses high frequency sound waves to target and ablate (or destroy) the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then performed to remove the part of the kidney with the mass. Robot-assisted laparoscopic high-intensity focused ultrasound for thermal ablative therapy may be safer and help doctors see the tumor better when performing kidney surgery.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of laparoscopic high-intensity focused ultrasound (HIFU) for the treatment of localized primary renal cancer to evaluate histological accuracy in successful ablation of the small renal mass, matched with intraoperative targeting. SECONDARY OBJECTIVES: I. To evaluate the safety and toxicity of laparoscopic HIFU for patients with primary renal cancer. II. To evaluate the technical success of laparoscopic HIFU ablation. OUTLINE: Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy. After completion of study treatment, patients are followed up at 2 days, 2 weeks, 1 month, 6 months, 12 months, and then annually for up to 3 years.

Conditions

• Renal Carcinoma
• Renal Mass

Interventions

Type	Name	Description
PROCEDURE	Robot-Assisted Laparoscopic Surgery	Undergo robot-assisted laparoscopic HIFU ablation
PROCEDURE	High-Intensity Focused Ultrasound Ablation	Undergo robot-assisted laparoscopic HIFU ablation
PROCEDURE	Therapeutic Laparoscopic Surgery	Undergo laparoscopic partial nephrectomy
DEVICE	Sonatherm 600i Ultrasonic Lesion Generating System	Device used for high-intensity focused ultrasound ablation

Timeline

• Start date: 2017-12-18
• Primary completion: 2018-12-18
• Completion: 2019-12-18
• First posted: 2015-02-24
• Last updated: 2017-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study