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

NCT02539004 | Completed

• 1 other identifier: 0117-15
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

kidney stones; ureteral stones

Outcome Measures

Primary Outcomes (1)

• US identification of ureteral stone seen on NCCT

  up to 3 months after NCCT

Interventions

Ultrasound study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with proved urolithiasis on NCCT

You may qualify if:

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

You may not qualify if:

• Inability to perform a US study.
• Pacemaker

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam medical center

Haifa, Select A State, 3109601, Israel

Location

MeSH Terms

Conditions

Urolithiasis; Ureterolithiasis; Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Officials

• Eyal Bercovich, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: June 1, 2015
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

IL (1)