Intraoperative Near Infrared Spectroscopy of Kidney for P... | NCT05146947

Studies
Intraoperative Near Infrared Spectroscopy of Kidney for Prediction of Acute and Sub-acute Kidney Injury in Partial Nephrectomy

NCT05146947

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 7, 2021Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Kidney Injury

Interventions

near infrared spectroscopy

Countries

Not provided

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Nov 20, 2021

First Submission Date that Met QC Criteria

Dec 5, 2021

First Posted Date

Dec 7, 2021Actual

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 5, 2021

Last Update Posted Date

Dec 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Intra-operative NIRS measurements of kidney during partial nephrectomy, after reperfusion, for monitoring ischemia and prediction of postoperative renal dysfunction.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
near infrared spectroscopy	Device	near infrared spectroscopy monitoring on kidney after reperfusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Kidney Injury	An increase in serum creatinine by 0.3mg/dL or more within 48 hours compared with admission creatinine level or an increase in serum creatinine above 1.5 times baseline within 7 days of admission	7 days post operative and during 6 months post-surgery.

Secondary Outcomes

Measure	Description	Time Frame
Surgical complications	Vascular/Bleeding ect.	7 days post operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidates for partial nephrectomy at Tel Aviv Medical Center who will consent to participate.

Exclusion Criteria:

Patients unable to give consent,
Patients who were lost to follow up during the first 7 post-operative days.

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orr Goren, Dr	Contact	+972527360972		org@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Orr Goren, Dr	Tel Aviv Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013057	Spectrum Analysis

Browse Leaves

Not provided

Browse Branches

Not provided