NCT01907932

Brief Summary

In internal medicine, assessment of spleen size on physical examination is an extremely important part of the overall evaluation of patients with many illnesses. Examination of the spleen is also one of the core competencies that the investigators expect the students and residents to learn as part of their training. Unfortunately, the sensitivity and specificity of examination of the spleen at the bedside is not very good. The investigators wish to determine if medical residents can be taught to use hand carried ultrasound to accurately assess spleen size. Doing so would make physical examination of the spleen obsolete and transform training objectives for medical trainees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

July 22, 2013

Last Update Submit

April 12, 2017

Conditions

Keywords

splenomegalyultrasoundVScan

Outcome Measures

Primary Outcomes (1)

  • longitudinal measure of spleen in centimeters

    1 day

Secondary Outcomes (1)

  • Diagnosis of spleen size

    1 day

Other Outcomes (3)

  • time to complete VScan examination

    1 day

  • Image quality and best views

    1 day

  • Diagnostic Certainty

    1 day

Study Arms (1)

normal and various degrees splenomegaly

EXPERIMENTAL

VScan Ultrasound (GE Healthcare, USA) all subjects will be measured by 5 different medical residents Each resident will complete questionaire: 1. Adequacy of image quality 2. What is best view obtained 3. Greatest Longitudinal Measure 4. Diagnosis 5. Diagnostic Certainty 6. Time to Complete exam

Device: VScan Ultrasound (GE Healthcare, USA)

Interventions

VScan Ultrasound used to determine spleen size and the other qualities described in the arm description.

Also known as: handheld ultrasound (HCU)
normal and various degrees splenomegaly

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients in the practices of hematologists at VGH who are expected to have normal size spleens as well as various degrees of splenomegaly

You may not qualify if:

  • will exclude patients who cannot speak English or who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Coastal Health (VCHRI/VCHA)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Splenomegaly

Condition Hierarchy (Ancestors)

HypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Graydon S Meneilly, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, UBC Department of Medicine

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 25, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations