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

NCT ID: NCT02539004

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2022-10-26

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".

Conditions

Urolithiasis; Ureterolithiasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Ultrasound study

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Bercovich, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam medical center

Haifa, Select A State, Israel

Countries

Israel

Other Identifiers

0117-15

Identifier Type: -

Identifier Source: org_study_id