An interventional study of HydroMARK Plus Clip in Breast Neoplasm, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Diagnostic
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Among 46 studies in Breast Neoplasms by University of Alabama at Birmingham — 7 open to participants now, 11 under way, none of them phase 3. Breast Neoplasms · University of Alabama at Birmingham.
Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, this one is the 4th largest by planned enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2025, is one of 22 with no phase, reaches primary completion later than 5 of the 10 other live ones, and was the 43rd registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →7 of the 46 studies in Breast Neoplasms by University of Alabama at Birmingham are open now, in 1 country. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+
University of Alabama at Birmingham · Sites in United States
Ages 60+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 90 Years · female · no healthy volunteers.
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46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 13
First in 2000; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 35 across the 42 interventional studies, 200 across the 3 observational. Of the 32 that completed or were terminated, 11 (34%) have results posted.
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University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
3 of the studies in Breast Neoplasms by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06924788University of Alabama at BirminghamVideo-Conferenced Stress Management and Relaxation Training (VSMART) For Alabama Breast Cancer Survivors | 2026-12-31 |
| NCT04332588University of Alabama at BirminghamMonitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI | 2027-08 |
| NCT03368729University of Alabama at BirminghamNiraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer | 2027-11-01 |
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Among the 46 studies in Breast Neoplasms by University of Alabama at Birmingham, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.
Study objectives
Primary objective
Assess the successful retrieval rates of the HydroMARK Plus clip
Secondary objective
Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a previously placed HydroMARK T3 coil clip or a clip made by another manufacturer and will have a HydroMARK Plus clip placed during the scout localization procedure for this study. Breast surgeons will perform retrieval and then complete a satisfaction survey to compare the two clips.
Device: HydroMARK Plus Clip
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
Retrieval rate of the HydroMARK Plus clip.
The primary endpoint of HydroMARK Plus retrieval rate will be estimated with % and two-sided 95% CI using normal approximation. A paired McNemar Test will be used to compare HydroMARK Plus retrieval rate and HydroMARK retrieval rate, and the 95% CI for the difference of retrieve rate will be estimated using the Newcombe's Score method.
Time frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.
Surgeon satisfaction will be evaluated using a Likert scale survey.
Time frame: Date of retrieval surgery to 1 week.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 28 months is below that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Alabama at Birmingham →