Breast NeoplasmNCT06294574
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
A study testing HydroMARK Plus Clip in people with Breast Neoplasm, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- HydroMARK Plus Clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy clips scheduled for surgery with SCOUT localization
Who cannot join
- Patients who didn't have surgery, patients younger than 18 years old
- Patients older than 90 years old
- Inmates
- Non-English speakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Kirklin Clinic
Birmingham, Alabama, 35249
Quenteeria Mooney, 205-996-1082, qmooney@uabmc.edu
Ceren Yalniz, MD
About this study
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.
Read the detailed description
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
- Conditions
- Breast Neoplasm
- Being tested
- HydroMARK Plus Clip
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroMARK Plus ClipDevice
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Hydromark plus clip placement | Experimental | 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. Receives: Device: HydroMARK Plus Clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
Secondary outcomes (1)
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.
Surgeon satisfaction will be evaluated using a Likert scale survey.
Measured: Date of retrieval surgery to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start5 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mammotome
- Responsible party
- Principal investigator, Ceren Yalniz, University of Alabama at Birmingham
- Investigators
- Ceren Yalniz, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294574
- Sponsor's protocol ID
- IRB-300011943
- Other IDs
- 000544990
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
- ClinicalTrials.gov ID
- NCT06294574
- Acronym / sponsor ID
- IRB-300011943
- Conditions
- Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Mammotome
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydromark plus clip placement | Experimental | Device: HydroMARK Plus ClipPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with biopsy clips scheduled for surgery with SCOUT localization
Key exclusion criteria (4 listed)
- Patients who didn't have surgery, patients younger than 18 years old
- Patients older than 90 years old
- Inmates
- Non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroMARK Plus ClipEach patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed. | Device | Hydromark plus clip placement |
Primary outcome
Retrieval rate of the HydroMARK Plus clip.
Time frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
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.
1 secondary outcome
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.
Time frame: Date of retrieval surgery to 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ceren Yalniz, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HydroMARK Plus Clip in people with Breast Neoplasm, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quenteeria Mooney (205-996-1082, qmooney@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrieval rate of the HydroMARK Plus clip. (time frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.