Validation of Low Dose CT for Diagnosis of Urolithiasis | NCT03656913

Studies
Validation of Low Dose CT for Diagnosis of Urolithiasis

NCT03656913

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Terminated

Last Update Posted

Feb 18, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Nephrolithiasis
Ureterolithiases

Interventions

Extremely low dose CT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor recruitment

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Sep 28, 2020Actual

Completion Date

Sep 28, 2020Actual

First Submitted Date

Aug 31, 2018

First Submission Date that Met QC Criteria

Aug 31, 2018

First Posted Date

Sep 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators have developed an extremely low dose renal computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of a single view abdominal radiograph. The investigators plan to test this exam in patients with known or suspected urolithiasis undergoing clinically indicated CT.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Patients will receive both the clinically indicated and extremely low dose CT exams	Diagnostic Test: Extremely low dose CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extremely low dose CT	Diagnostic Test	Patients undergoing clinically indicated CT will also receive the extremely low dose CT	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic performance of extremely low dose CT	Sensitivity	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric and young adult patients (ages 4 to <21 years)
Known or suspected urolithiasis
Undergoing clinically indicated CT of the abdomen/pelvis

Exclusion Criteria:

Pregnancy
Prior enrollment in the same study (no patient will be enrolled more than once)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew T Trout, MD	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center Burnet Campus		Cincinnati	Ohio	45229	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No data sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053040	Nephrolithiasis
D053039	Ureterolithiasis
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided