Trial Outcomes & Findings for The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies (NCT NCT04398537)
NCT ID: NCT04398537
Last Updated: 2023-12-20
Results Overview
This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
baseline through 1 hour (post biopsy mammogram/procedure)
Results posted on
2023-12-20
Participant Flow
Participant milestones
| Measure |
5mm Retraction of Clip Deployment Apparatus
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
133
|
|
Overall Study
COMPLETED
|
102
|
118
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
| Measure |
5mm Retraction of Clip Deployment Apparatus
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Overall Study
Physician Decision
|
10
|
15
|
Baseline Characteristics
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Baseline characteristics by cohort
| Measure |
5mm Retraction of Clip Deployment Apparatus
n=102 Participants
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
n=117 Participants
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
49 participants
n=99 Participants
|
59 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Ethnicity Not reported
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White Ethnicity Unknown
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black Ethnicity Not Reported
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian Non-Hispanic
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian Ethnicity Unknown
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic Non-Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Decline Race Non-Hispanic
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Decline Race Ethnicity Not Reported
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)This number of participants will be counted if their clip migrated more than 10mm from the biopsy site.
Outcome measures
| Measure |
5mm Retraction of Clip Deployment Apparatus
n=104 Participants
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
n=119 Participants
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
|
46 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)Outcome measures
| Measure |
5mm Retraction of Clip Deployment Apparatus
n=104 Participants
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
n=119 Participants
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
|
46 Participants
|
44 Participants
|
PRIMARY outcome
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)Population: This was only measured on the 5mm retraction group
Outcome measures
| Measure |
5mm Retraction of Clip Deployment Apparatus
n=46 Participants
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
|
12.1 mm
Standard Deviation 14.9
|
—
|
PRIMARY outcome
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)Population: This was only measured on the control group
Outcome measures
| Measure |
5mm Retraction of Clip Deployment Apparatus
The participants in this group will have clip placement 5mm in front of the biopsy site site.
5mm retraction of clip deployment apparatus.: Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
|
no Retraction of Clip Deployment Apparatus
n=44 Participants
These participants will the clip delivered at the biopsy site.
No retraction of clip deployment apparatus.: This is one method of standard of care and the clip will be deployed at the biopsy site.
|
|---|---|---|
|
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
|
—
|
9.8 mm
Standard Deviation 14.9
|
Adverse Events
5mm Retraction of Clip Deployment Apparatus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
no Retraction of Clip Deployment Apparatus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place