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Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS (PROGRESS)

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ClinicalTrials.gov Identifier: NCT02948361
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
QT Ultrasound LLC

Tracking Information
First Submitted Date  ICMJE September 1, 2016
First Posted Date  ICMJE October 28, 2016
Last Update Posted Date February 25, 2019
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
QT Ultrasound scans [ Time Frame: Scan session is 2 to 3 hours ]
The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02948361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Official Title  ICMJE Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Brief Summary

Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations.

If available, subjects may provide copies of their breast imaging exams and related reports.

Demographics and medical history will be collected.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Volunteer Subjects
Intervention  ICMJE Other: QT Ultrasound Breast Scan
Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per American College of Radiology (ACR) recommendations.
Study Arms  ICMJE Experimental: QT Ultrasound breast scan
Intervention: Other: QT Ultrasound Breast Scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • Willing and able to provide written, signed informed consent
  • Willing and able to comply with all study procedures

Exclusion Criteria:

  • Inability to tolerate the scan
  • Present infection risk
  • Allergies to device materials
  • Inability to successfully "fit" breast into the investigational device
  • Currently pregnant as reported by the subject
  • Body weight greater than 400 lbs. (180 kg)
  • Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948361
Other Study ID Numbers  ICMJE BR004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party QT Ultrasound LLC
Study Sponsor  ICMJE QT Ultrasound LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rajni Natesan, MD Chief Medical Officer
PRS Account QT Ultrasound LLC
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP