Microwave Coagulation in Partial Nephrectomy Protocol

NCT01931462 | Terminated Results DMC

• 1 other identifier: 2013-1080
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer of the Kidney; Renal Cancer; Renal Neoplasms; Neoplasms, Kidney

Outcome Measures

Primary Outcomes (1)

• To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.

  We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)

  30 days prior to surgery (Baseline) and 6 weeks post surgery

Secondary Outcomes (7)

• Blood Loss

  During the operation

• Operative Time

  During the operation

• Clamp Time

  During the operation

• Change in Renal Function

  Within 30 days prior to operation and 6 weeks post operation

• Change in Functional Renal Volume

  Within 30 days prior to operation and 6 weeks post-operation

Study Arms (1)

Certus 140™

EXPERIMENTAL

During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.

Device: Microwave pre-coagulation

Interventions

Microwave pre-coagulation DEVICE

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.

Certus 140™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a solitary, polar, clinical T1 renal mass
• Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.
• Women of child-bearing potential must have negative serum or urine pregnancy test
• Patient must be able to give written informed consent
• Patient must be 18 years or older
• No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery

You may not qualify if:

• T stage greater than clinical T1
• Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
• Prior surgery or radiation therapy to the region of interest
• Patient has a single functioning kidney
• Patient has an uncorrectable coagulopathy
• Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Director of Clinical Research, Department of Surgery
• Organization: University of Wisconsin

clinicalresearch@surgery.wisc.edu

608-262-0540

Study Officials

• E Jason Abel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 26, 2018
• Results First Posted: November 20, 2017

Record last verified: 2018-01

Locations

US (1)