Trial Outcomes & Findings for Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc ) (NCT NCT04815291)

NCT ID: NCT04815291

Last Updated: 2024-05-21

Results Overview

Number of visits to the breast centre for an invasive procedure between biopsy and surgery

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: through study completion, an average of 6 months
• Results posted on: 2024-05-21

Participant Flow

Participant milestones

Measure	Device Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Overall Study STARTED	93
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Device Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	4
Overall Study Surgery not planned and subject not operated.	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Device n=92 Participants Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Age, Continuous	63.3 years STANDARD_DEVIATION 8.47 • n=92 Participants
Sex: Female, Male Female	92 Participants n=92 Participants
Sex: Female, Male Male	0 Participants n=92 Participants
Region of Enrollment Canada	92 participants n=92 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 6 months

Number of visits to the breast centre for an invasive procedure between biopsy and surgery

Outcome measures

Measure	Device n=85 Participants Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Number of Participants Invasive Visits	5 Participants

SECONDARY outcome

Timeframe: through study completion; an average of 6 months

Device-related adverse event rate

Outcome measures

Measure	Device n=93 Participants Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Number of Participants With Adverse Events	1 Participants

SECONDARY outcome

Timeframe: through study completion; an average of 6 months

Successful Procedure is absence of close margins (<2mm), positive margins (tumor on ink) or requirement for re-excision.

Outcome measures

Measure	Device n=85 Participants Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector
Performance	84 Participants

Adverse Events

Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Device n=93 participants at risk Receives SCOUT at biopsy Receives SCOUT at biopsy: SCOUT Reflector

Blood and lymphatic system disorders Hemorrhage

1.1% 1/93 • Number of events 1 • Adverse events were collected through study completion; average of 6 months. The following adverse events of interest and device deficiencies were collected: Adverse reaction to material, Device Migration, Inaccurate location detection, Inaccurate deployment, Infection Tissue/vascular trauma, and any AE that, in the opinion of the investigator, has a causal relationship (probable or definite) to the device or procedure, or any device deficiency, whether or not associated with an adverse event. All AEs collected were treatment related.

Additional Information

Casey Holland

Merit Medical Systems Inc.

Phone: 6178420251

Email: casey.holland@merit.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place