NCT01349244

Brief Summary

The purpose of this study is to determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found by CT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

May 4, 2011

Last Update Submit

July 8, 2014

Conditions

HydronephrosisRenal Colic

Keywords

hydronephrosisCTPOC US

Outcome Measures

Primary Outcomes (1)

  • hydronephrosis bedside ultrasound

    To determine the overall sensitivity and specificity of hydronephrosis on point-of-care bedside ultrasound to identify hydronephrosis as compared to hydronephrosis found on by CT.

    Sept 2011-Jan 2013

Secondary Outcomes (1)

  • hydronephrosis bedside ultrasound

    Sept 2011-Jan 2013

Other Outcomes (1)

  • hydronephrosis

    Sept 2011-Jan 2013

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a prospective observational study involving a convenience sample of all ED patients scheduled for NCT at some point during their emergency department visit.

You may qualify if:

  • Emergency Department patients 18 yrs or older with suspected renal colic in whom the clinician intends to obtain a CT scan to diagnose kidney stone.
  • Informed consent will be required prior to enrollment in the study.

You may not qualify if:

  • Known renal disease (any ESRD, transplant, PCKD), dementia, trauma, language barrier, incarcerated patients, and patients who do not undergo CT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University, Emergency Department

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

HydronephrosisRenal Colic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher L Moore, MD

    Yale University

    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

May 4, 2011

First Posted

May 6, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations

US(1)