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

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539004
• Other study ID #: 0117-15
• Status: Completed
• Start date: June 2015
• Est. completion date: October 26, 2022

Study information

• Verified date: November 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Inability to perform a US study.

• Pacemaker

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureterolithiasis
• Urinary Calculi
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa	Select A State

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	US identification of ureteral stone seen on NCCT		up to 3 months after NCCT