Clinical trial · Observational
Tracking Renal Tumors After Cryoablation Evaluation
Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Boston Scientific acquisition of BTG/Galil Medical - business decision made to stop follow-up early
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Kidney lesions amenable to cryoablation
- description
- Kidney lesions treated with cryoablation.
- interventionNames
- Device: Cryoablation
Primary outcomes (9)
- measure
- Changes in Lesion Size
- timeFrame
- Baseline and months 6, 12, 24, 36, 48 and 60
- description
- Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.
- measure
- Renal Function Status
- timeFrame
- Baseline and months 6, 12, 24, 36, 48 and 60
- description
- Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Suggested 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. Suggested 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).
References
Publications (6)
- BACKGROUNDGoldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8. PMID 1387912
- BACKGROUNDSaliken 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. PMID 12206845
- BACKGROUNDRewcastle 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. PMID 10389867
- BACKGROUNDRewcastle 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. PMID 9354166
- BACKGROUNDLevey 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. PMID 10075613
- BACKGROUNDFinley 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. PMID 18550087