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NCT04671329 · ClinicalTrials.gov registry record · NA

A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy

A NA study, sponsored by Hologic.

Completed
Registry status
NA
Development phase
67
Enrollment target

NCT04671329 is a NA study that has completed, run by Hologic. The registered enrollment target is 67 participants.

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The verdict

NCT04671329, a NA study, has completed, sponsored by Hologic.

COMPLETED
Registry status
NA
Development phase
67 participants
Enrollment target

Study Summary

Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.

Interventions

  • DEVICE Affirm Contrast Biopsy procedure

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2021-03-05
Est. Completion 2022-08-18
Phase NA

Sponsor

Hologic

21 total trials

What the Registry Record Tells You About NCT04671329

The ClinicalTrials.gov registry entry for NCT04671329 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hologic, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Affirm Contrast Biopsy procedure is the first listed.

NCT04671329 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04671329 about?

NCT04671329 is a clinical study titled "A Prospective, Multi-site Clinical Study to Collect User Feedback Using Affirm® Contrast Biopsy". Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contr...

What is the current status of trial NCT04671329?

This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2021-03-05. Estimated completion is 2022-08-18.

What interventions are being tested in trial NCT04671329?

The interventions under investigation include: Affirm Contrast Biopsy procedure (DEVICE).

Who is sponsoring clinical trial NCT04671329?

This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.