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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: Completed NA study, sponsored by Hologic.
NCT04671329 is a NA study that has completed, run by Hologic. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Technical success was defined as successfully completing the breast biopsy procedure with the Affirm Contrast Biopsy system for each participant (60 participants equals 60 procedures).
Interventions
- DEVICE Affirm Contrast Biopsy procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2022-08-18 |
| Phase | NA |
What the finished NCT04671329 record still lists
NCT04671329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Affirm Contrast Biopsy procedure is the first listed.
NCT04671329 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04671329's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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