US-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".

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam medical center

Haifa, Select A State, 3109601, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Inability to perform a US study.
Pacemaker

Treatment and study plan

Ultrasound study

Other

Ultrasound study using real-time image fusion with a previous NCCT

Primary outcomes

US identification of ureteral stone seen on NCCT

Time frame: up to 3 months after NCCT

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Sep 2, 2015
Registry last updated: Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed