Clinical trial · Observational
A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study
NCT02814292CI-TRIAL-00022736completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Estimate the sensitivity of the iBE device examinations using imaging results
- timeFrame
- through study completion an average of 12 months
- measure
- Estimate the specificity of the iBE device using imaging results
- timeFrame
- through study completion an average of 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 18 years or older * women or men with symptomatic breast lump by palpation or imaging Exclusion Criteria: * under 18 years of age
References
Publications (1)
- DERIVEDBroach 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 27793162