NCT05199701Active, not recruitingNot Applicable
Prospective Case Collection Study for New Mammography Technologies
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hologic, Inc.
- Enrollment
- 7,500
- Locations
- 29
- Primary Endpoint
- Clinically acceptable image quality of the Investigational Device.
Study Overview
Brief Summary
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is female of any race and ethnicity.
- •Subject is at least 35 years old.
- •Subject is indicated for a screening or diagnostic mammogram or breast biopsy.
Exclusion Criteria
- •Subject is pregnant or thinks she may be pregnant
- •Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view.
- •Subject previously participated in the study.
Arms & Interventions
Investigational Mammogram Exam
Experimental
Intervention: Mammography (Device)
Outcomes
Primary Outcomes
Clinically acceptable image quality of the Investigational Device.
Time Frame: 4 years
Questionnaire will be used to measure outcomes
Mammograms can be safety acquired on the Investigational Device.
Time Frame: 4 years
Will be determined using the AE assessment.
Secondary Outcomes
- The ease of positioning and usability of the Investigational Device.(4 years)
- Subject assessment of comfort of the Investigational Device.(4 years)
Investigators
Study Sites (29)
Loading locations...
Similar Trials
Completed
Not Applicable
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective CraniotomyCerebrospinal Fluid LeakageNCT01295619Kuros Biosurgery AG41
Withdrawn
Not Applicable
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During ChildbirthChildbirthNCT06698185Materna Medical
Completed
Not Applicable
The Clinical Efficacy of RENASYS TOUCH NPWT System in the Management of Acute, Sub-acute and Chronic WoundsWound and InjuriesSurgical Wound DehiscenceNCT02565043Smith & Nephew, Inc.80
Not yet recruiting
Not Applicable
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.Adenoidal DisorderOtorhinolaryngologic DiseasesNasal DiseaseTonsillitisNCT06478433Pharmaluce srl90
Active, not recruiting
Not Applicable
Cook Venous Valve System for Treatment of Chronic Venous InsufficiencyVenous Insufficiency of LegNCT05883943MED Institute Inc.4