# The PIONEER-01 Study of the Imagio Breast Imaging System

> **NCT01943916** · NA · COMPLETED · sponsor: **Seno Medical Instruments Inc.** · enrollment: 2105 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DEVICE:** Imagio OA/US (US and OA/US)
- **DEVICE:** Imagio gray scale ultrasound

## Key facts

- **NCT ID:** NCT01943916
- **Lead sponsor:** Seno Medical Instruments Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-12-21
- **Primary completion:** 2015-09-09
- **Final completion:** 2015-09-09
- **Target enrollment:** 2105 (ACTUAL)
- **Last updated:** 2023-02-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01943916

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01943916, "The PIONEER-01 Study of the Imagio Breast Imaging System". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT01943916. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*