Clinical trial · Interventional
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
NCT06294574CI-TRIAL-00095600recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HydroMARK Plus Clip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hydromark plus clip placement
- description
- 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.
- interventionNames
- Device: HydroMARK Plus Clip
Primary outcomes (1)
- measure
- Retrieval rate of the HydroMARK Plus clip.
- timeFrame
- Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with biopsy clips scheduled for surgery with SCOUT localization Exclusion Criteria: * Patients who didn't have surgery, patients younger than 18 years old * Patients older than 90 years old * Inmates * Non-English speakers
References
Publications (0)
Data not yet available
No reference posted for this study.