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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 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.

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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.

Conditions Studied

Breast Tumor

Interventions

  • DEVICE RFID Localization
  • DEVICE Wire Localization
  • DEVICE RFID and Wire Localization

Study Locations (1)

Missouri

  • University of Missouri - Columbia

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2018-10-18
Est. Completion 2021-04-19
Phase NA

Sponsor

University of Missouri-Columbia

291 total trials

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What the Registry Record Tells You About NCT03684408

The ClinicalTrials.gov registry entry for NCT03684408 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,421-participant average among 6 other Breast Tumor trials with a reported enrollment target (97% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.