NCT01931462

Microwave Coagulation in Partial Nephrectomy Protocol

A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long. This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided. The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.

Conditions

• Cancer of Kidney

Interventions

Type	Name	Description
DEVICE	Microwave pre-coagulation	The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss.

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-08-29
• Last updated: 2018-02-26
• Results posted: 2017-11-20

Locations

1 site across 1 country: United States