NCT00388830

Brief Summary

The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

First QC Date

October 13, 2006

Last Update Submit

November 1, 2012

Conditions

Gallbladder Diseases

Keywords

GallbladderUltrasoundEmergency Medicine

Outcome Measures

Primary Outcomes (4)

  • time to perform scan

  • diagnosis of pathology

  • performance of adequate measurement

  • overall adequacy of the scan

Interventions

UltrasoundPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the ages of 18 and 75
  • Ability to consent for study

You may not qualify if:

  • Inability to give informed consent
  • Known pregnancy
  • Prior cholecystectomy
  • Inability to consume a fast food breakfast
  • Known history of cholelithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Robert O'Connor, MD, MPH

    Christiana Care Health Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 17, 2006

Study Start

May 1, 2006

Study Completion

July 1, 2007

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

US(1)