Trial Outcomes & Findings for Long Term Use of SAVI SCOUT: Pilot Study (NCT NCT03015649)

NCT ID: NCT03015649

Last Updated: 2020-05-11

Results Overview

The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 31 - 365 days prior to surgery
• Results posted on: 2020-05-11

Participant Flow

Participant milestones

Measure	SCOUT Device All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Use of SAVI SCOUT: Pilot Study

Baseline characteristics by cohort

Measure	SCOUT Device n=34 Participants All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized African American	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	11 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Node Positive	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 31 - 365 days prior to surgery

The primary endpoint of this study is successful surgery. Successful surgery (defined as one where the device stays in place and can be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery. Unsuccessful surgery is defined as one where the device does not stay in place and/or cannot be removed successfully during surgery) when this device is placed 31 - 365 days prior to surgery.

Outcome measures

Measure	SCOUT Device n=34 Participants All study participants received the same treatment assignment, i.e. lesion localization with the SCOUT device 31 - 365 days prior to surgery. Each participant underwent the SAVI SCOUT Surgical Guidance System procedure.
Number of Participants Considered to Have a Successful Surgery	34 Participants

Adverse Events

SCOUT Device

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

Women's Imaging Director

Envision Healthcare Scientific Intelligence, Inc.

Phone: 9549397729

Email: clinicaltrials@shcr.com

Results disclosure agreements

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