Cryoablation Versus Radiofrequency Ablation for Small Ren... | NCT00922948

Studies
Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

NCT00922948

Sponsor

St. Joseph's Healthcare Hamilton

Status

Withdrawn

Last Update Posted

Jul 27, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Renal Cancers

Interventions

Cryoablation
Radiofrequency ablation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jun 16, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2016

Last Update Posted Date

Jul 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.

Detailed Description

By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cryoablation	Experimental		Procedure: Cryoablation
Radiofrequency ablation	Active Comparator	Radiofrequency ablation	Procedure: Radiofrequency ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cryoablation	Procedure	Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.	Cryoablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment failure rate.		Baseline, Weeks 6, 12, 24, 36, 48

Secondary Outcomes

Measure	Description	Time Frame
Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.		Baseline, Weeks 6, 12, 24, 36 and 48
Average percentage decrease in tumor size.		Baseline, Weeks 6, 12, 24, 36 and 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with tumors that progress in size while on a watchful waiting protocol;
Patients with multiple tumors;
Patients with a tumor in a solitary kidney;
Patients with poor renal function and a renal tumor;
Patients with significant co-morbidities that may benefit from a less invasive approach.

Exclusion Criteria:

Large tumors > 4.0cm;
Unable to have a general anesthetic;
Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
Uncorrectable bleeding diathesis;
Evidence of metastatic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anil Kapoor, MD	McMaster Institute of Urology, McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton		Hamilton	Ontario	L8N 4A6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003452	Cryosurgery
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative
D000078702	Radiofrequency Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided