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

• ClinicalTrials.gov Identifier: NCT02948361
• Recruitment Status: Active, not recruiting
• First Posted: October 28, 2016
• Last Update Posted: March 18, 2021
• Sponsor: QT Ultrasound LLC
• Information provided by (Responsible Party): QT Ultrasound LLC

Tracking Information

• First Submitted Date: September 1, 2016
• First Posted Date: October 28, 2016
• Last Update Posted Date: March 18, 2021
• Study Start Date: August 2016
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Volunteer Subjects

Intervention

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

Experimental: QT Ultrasound breast scan

Intervention: Other: QT Ultrasound Breast Scan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 26, 2016): 1500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02948361
• Other Study ID Numbers: BR004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: QT Ultrasound LLC
• Study Sponsor: QT Ultrasound LLC
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: QT Ultrasound LLC
• Verification Date: March 2021