Tracking Renal Tumors After Cryoablation Evaluation

NCT ID: NCT01117779

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-09
• Study Completion Date: 2020-11-24

Brief Summary

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

Detailed Description

The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE. Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.

Conditions

Kidney Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Kidney lesions amenable to cryoablation

Kidney lesions treated with cryoablation.

Cryoablation

Intervention Type: DEVICE

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Interventions

Cryoablation

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Intervention Type: DEVICE

Other Intervention Names

Visual-ICE cryoablation system; SeedNet cryoablation system; PresIce cryoablation system; IceRod cryoablation needle; IceRod PLUS cryoablation needle; IceRod CX cryoablation needle; IceEDGE 2.4 cryoablation needle; IceSphere cryoablation needle

Eligibility Criteria

Inclusion Criteria

• Patient is at least 18 years of age.
• Patient has a renal lesion suspicious for malignancy.
• Patient is to undergo renal lesion cryoablation via a Galil Medical cryoablation system using Galil Medical needles for treatment of primary or recurrent disease.
• Patient is to be available for long-term follow-up per the enrolling physician's standard care practices.
• Patient has provided written informed consent.

Exclusion Criteria

• Patient is either currently using or has used within the last 30 days an investigational product of any type.
• Patient has metastatic disease to or from the kidney.
• Patient has had previous therapy on the index lesion (e.g. radiofrequency, cryoablation, partial nephrectomy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Savage, MD

Role: STUDY_CHAIR

Medical University of South Carolina

Peter Clark, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

University of California Irvine

Orange, California, United States

Kaiser Permanente

Denver, Colorado, United States

University of Kentucky

Lexington, Kentucky, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Columbia University

New York, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.

Reference Type: BACKGROUND

PMID: 1387912 (View on PubMed)

Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. doi: 10.1016/s0090-4295(02)01681-3.

Reference Type: BACKGROUND

PMID: 12206845 (View on PubMed)

Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.

Reference Type: BACKGROUND

PMID: 10389867 (View on PubMed)

Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.

Reference Type: BACKGROUND

PMID: 9354166 (View on PubMed)

Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

Reference Type: BACKGROUND

PMID: 10075613 (View on PubMed)

Finley DS, Beck S, Box G, Chu W, Deane L, Vajgrt DJ, McDougall EM, Clayman RV. Percutaneous and laparoscopic cryoablation of small renal masses. J Urol. 2008 Aug;180(2):492-8; discussion 498. doi: 10.1016/j.juro.2008.04.019. Epub 2008 Jun 11.

Reference Type: BACKGROUND

PMID: 18550087 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CUC10-RNL02

Identifier Type: -

Identifier Source: org_study_id