A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study
1 other identifier
observational
89
1 country
1
Brief Summary
Validation of the PEFS to detect breast tumors will be performed by means of a prospective trial. Subjects will participate for 1 clinic visit. Readings from the PEFS will be studied for reproducibility and predictive ability. Data analysis will be iterative, moving on with each modification of the device until the final prototype is created.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedJune 27, 2016
June 1, 2016
8 months
June 14, 2016
June 22, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Estimate the sensitivity of the iBE device examinations using imaging results
through study completion an average of 12 months
Estimate the specificity of the iBE device using imaging results
through study completion an average of 12 months
Eligibility Criteria
18 years of age and older Women and men with symptomatic breast lump either by palpation or imaging
You may qualify if:
- years or older
- women or men with symptomatic breast lump by palpation or imaging
You may not qualify if:
- under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- UE LifeSciences Inc.collaborator
Study Sites (1)
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
Broach RB, Geha R, Englander BS, DeLaCruz L, Thrash H, Brooks AD. A cost-effective handheld breast scanner for use in low-resource environments: a validation study. World J Surg Oncol. 2016 Oct 28;14(1):277. doi: 10.1186/s12957-016-1022-2.
PMID: 27793162DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 27, 2016
Study Start
June 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
June 27, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share