Clinical trial · Interventional
IGAR-Breast TeleOp Trial
IGAR-Breast Teleoperative Clinical Investigation
NCT03734432CI-TRIAL-00035689IGAR-Breast-TOunknownN/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)
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IGAR-Breast TeleOp | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- description
- IGAR-Breast TeleOp
- interventionNames
- Device: IGAR-Breast TeleOp
Primary outcomes (1)
- measure
- ability for IGAR-Breast to perform breast biopsies teleoperatively
- timeFrame
- at time of sampling and pathological evaluation
- description
- analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist
Secondary outcomes (1)
- measure
- number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI Exclusion Criteria: * Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study
References
Publications (0)
Data not yet available
No reference posted for this study.