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

November 22, 2022 updated by: Rambam Health Care Campus

Ultrasound Non-contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Select A State
      • Haifa, Select A State, Israel, 3109601
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with proved urolithiasis on NCCT

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to perform a US study.
  • Pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Eyal Bercovich, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0117-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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