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

Completed

• Conditions: Urolithiasis; Ureterolithiasis

• Registration Number: NCT02539004
• Lead Sponsor: Rambam Health Care Campus

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 available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• Inability to perform a US study.
• Pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
US identification of ureteral stone seen on NCCT	up to 3 months after NCCT

Trial Locations

Locations (1)

Rambam medical center; 🇮🇱 Haifa, Select A State, Israel