Percutaneous Cryoablation of Central Kidney Tumours With... | NCT05461027

Studies
Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion

NCT05461027

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Kidney Cancer

Interventions

Not provided

Countries

France

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jul 12, 2022

First Submission Date that Met QC Criteria

Jul 12, 2022

First Posted Date

Jul 15, 2022Actual

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

Dec 24, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Percutaneous cryoablation is an alternative to urological surgery for T1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of the technique of percutaneous cryoablation of central renal tumours with temporary balloon obliteration of the renal artery		Files analysed retrospectively from January 01, 2018 to December 31, 2021 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Adult subject (≥18 years)
Subject who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021
Subject who has not expressed his/her opposition, after information, to the re-use of his/her data for the purpose of this research.

Exclusion criteria :

Subject having expressed his/her opposition to participate in the study
Subject under legal protection, guardianship or curatorship

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult subject (≥18 years) who has undergone cryoablation of a central kidney tumour with temporary occlusion of the renal artery by an endovascular balloon at the HUS during the period 01/01/2018 to 30/12/2021

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre-Alexis AUTRUSSEAU, MD	Service d'Imagerie Interventionnelle - CHU de Strasbourg - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Imagerie Interventionnelle - CHU de Strasbourg - France		Strasbourg		67091	France

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