US-Non Contrast Computed Tomography Real-time Fusion for... | NCT02539004

Studies
US-Non Contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up

NCT02539004

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Nov 23, 2022Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Urolithiasis
Ureterolithiasis

Interventions

Ultrasound study

Countries

Israel

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

Nov 2022

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

Jun 2015

Primary Completion Date

Oct 26, 2022Actual

Completion Date

Oct 26, 2022Actual

First Submitted Date

Aug 31, 2015

First Submission Date that Met QC Criteria

Aug 31, 2015

First Posted Date

Sep 2, 2015Estimated

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

Nov 22, 2022

Last Update Posted Date

Nov 23, 2022Actual

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

Urolithiasis is a universal problem, a large part of patients will be affected by multiple stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. The high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT real-time fusion (Fusion) enables lesion assessment and follow up using both modalities as reference for each other. Our study proposes a novel approach for short term follow up of patients using Fusion instead of repeat NCCT exams.

the goal of the study is to create an initial proof of concept that Fusion is effective for follow up of known urinary stones.

the study is a prospective study on Patients with an obstructing ureteral stone found on a NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as a "Road Map".

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

70Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound study	Other	Ultrasound study using real-time image fusion with a previous NCCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
US identification of ureteral stone seen on NCCT		up to 3 months after NCCT

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NCCT within 3 months prior to the US study with proved Urolithiasis

Exclusion Criteria:

Inability to perform a US study.
Pacemaker

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

patients with proved urolithiasis on NCCT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eyal Bercovich, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam medical center		Haifa	Select A State	3109601	Israel

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis
D053039	Ureterolithiasis
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided