Trials / Unknown
UnknownNCT03734432
IGAR-Breast TeleOp Trial
IGAR-Breast Teleoperative Clinical Investigation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- McMaster University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure. A total of 5-10 participants will be consented for the pilot investigation. Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IGAR-Breast TeleOp | Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2019-03-31
- Completion
- 2019-12-31
- First posted
- 2018-11-08
- Last updated
- 2018-11-08
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03734432. Inclusion in this directory is not an endorsement.