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NCT03684408 · ClinicalTrials.gov registry record · NA
Radiofrequency Chip for Localization of Non-Palpable Breast Lesions
A NA study of Breast Tumor, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT03684408: Completed NA study of Breast Tumor, sponsored by University of Missouri-Columbia.
NCT03684408 is a NA study of Breast Tumor that has completed, run by University of Missouri-Columbia. The registered enrollment target is 38 participants, below the 1,421-participant average among 6 other Breast Tumor trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03684408, a NA study of Breast Tumor, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (tumors). The study will be conducted in two parts. The purpose of Part A is for physician training with the RFID device. Nine subjects will undergo RFID and wire localization prior to breast lesion excision. This will allow the breast radiologists and surgeons to become comfortable with RFID device placement and retrieval. Additionally, the investigators will pilot the data collection surveys and chart review methodology to be used in Part B. The purpose of Part B is to conduct a randomized clinical trial to assess whether RFID localization is non-inferior to wire localization for breast lesions. For this part, sixty subjects will be randomized to RFID (N=30) or wire localization (N=30) at time of enrollment. Surveys will be used to gather data from participants, radiologists, surgeons, and technologists/mammography nurses. A variety of data will be collected including, but not limited to, information on tumor size, location, depth; subject demographics; adequacy of tumor margins, re-excision rates, accuracy of wire or chip placement, and surgical complications.
Primary Outcome
Whether the surgeon was able to identify and remove the tumor
Conditions Studied
Interventions
- DEVICE RFID Localization
- DEVICE Wire Localization
- DEVICE RFID and Wire Localization
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2021-04-19 |
| Phase | NA |
What the finished NCT03684408 record still lists
NCT03684408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,421-participant average among 6 other Breast Tumor trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Tumor appearing as the primary indexed condition, and to 3 interventions - of which RFID Localization is the first listed.
NCT03684408 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03684408 about?
NCT03684408 is a clinical study titled "Radiofrequency Chip for Localization of Non-Palpable Breast Lesions". The purpose of the project is to compare Radiofrequency identification device (RFID) localization technique with the current clinical standard wire localization technique. The Investigator's hypotheses is that the RFID localization technique is non-inferior to wire localization for breast lesions (t...
What is the current status of trial NCT03684408?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2018-10-18. Estimated completion is 2021-04-19.
What conditions does trial NCT03684408 study?
This clinical trial studies the following conditions: Breast Tumor.
What interventions are being tested in trial NCT03684408?
The interventions under investigation include: RFID Localization (DEVICE), Wire Localization (DEVICE), RFID and Wire Localization (DEVICE).
Who is sponsoring clinical trial NCT03684408?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03684408 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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