Clinical trial · Interventional
Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists
Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
NCT06056843CI-TRIAL-00107307PUDcompletedN/AClinicalTrials.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)
Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.
Conditions
Conditions (2)
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 |
| Carcinoma in Situ | Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.
- interventionNames
- Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.
Primary outcomes (1)
- measure
- Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
- timeFrame
- Through study completion, an average of 1 year
- description
- Sensitivity, specificity and positive and negative predictive values of portable ultrasound device to detect breast cancer and carcinoma in situ with repeat clinical breast examination, mammography/ultrasound and/or cytology/core biopsy as the gold standard test.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical breast examination positive women with no debilitating illness. * Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers. Exclusion Criteria: * Women with confirmed diagnosis of breast cancer or those already treated for the disease.
References
Publications (0)
Data not yet available
No reference posted for this study.