Trials / Completed
CompletedNCT03202472
Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery
Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies radiofrequency technology in locating non-palpable breast lesions in patients undergoing surgery. Placing a miniature radiofrequency tag or microchip in the breast lesion before surgery and using a handheld device to guide doctors during surgery may improve surgical outcomes in patients with non-palpable breast lesions.
Detailed description
PRIMARY OBJECTIVES: I. Evaluate the feasibility of utilizing a new Federal Drug Administration (FDA)-cleared radiofrequency tag for localization of non-palpable breast lesions and provide preliminary data for a larger study. OUTLINE: Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. After completion of study, patients are followed up within 2 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implanted Medical Device | Radiofrequency tag |
| PROCEDURE | Mammography | Undergo mammogram for image-guided placement of radiofrequency tag |
| OTHER | Questionnaire Administration | Ancillary studies |
| PROCEDURE | Radiofrequency (RFID) -Guided Localization | Undergo radiofrequency-guided localization |
| PROCEDURE | Ultrasonography | Undergo ultrasound for image-guided placement of radiofrequency tag |
Timeline
- Start date
- 2017-08-03
- Primary completion
- 2018-01-12
- Completion
- 2019-02-01
- First posted
- 2017-06-28
- Last updated
- 2020-07-24
- Results posted
- 2020-07-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03202472. Inclusion in this directory is not an endorsement.