NCT02622269

Brief Summary

Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression. Evaluation of radiation dose, image quality and patients' experiences

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

December 2, 2015

Last Update Submit

February 24, 2016

Conditions

Urologic Diseases

Keywords

UrographyRadiation dosageimage enhancement

Outcome Measures

Primary Outcomes (1)

  • Radiation dose measured as Dose-area product

    Radiation dose for the investigated exposures, measured as Dose-area product

    Immediately

Secondary Outcomes (2)

  • Image quality measured with Visual Grading

    Immediately

  • Patient experience (questionnaire)

    Immediately after the procedure

Study Arms (2)

Patient-regulated compression

EXPERIMENTAL

Patient-regulated compression device

Device: Patient-regulated compression device

Standard compression

ACTIVE COMPARATOR

Standard compression device

Device: Standard compression device

Interventions

Patient-regulated compression deviceDEVICE

Compression of the abdomen with a patient-regulated compression device

Patient-regulated compression
Standard compression deviceDEVICE

Compression of the abdomen with the standard compression device

Standard compression

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with a request for a urographic study

You may not qualify if:

  • Emergency studies,
  • cannot participate actively with compression,
  • contraindications to compression of the abdomen,
  • pregnancy,
  • inability to understand the language of the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology

Örebro, 70185, Sweden

Location

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Håkan Geijer, MD, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)