Selene for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer
Selene - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test a new system to see if it can reduce the number of positive margins in breast lumpectomy procedures.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 12 months

12 months
False Positive Shaves Per Subject
Safety Outcome - Adverse Events
Safety Outcome - False Positive Shaves Per Subject
Safety Outcome - Patient Reported Outcome
The number of unaddressed positive margins per subject.
The occurrence of at least one unaddressed positive margin for a subject.

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Device
1 of 2

Active Control

Experimental Treatment

333 Total Participants · 2 Treatment Groups

Primary Treatment: Selene · No Placebo Group · N/A

Device
Device
Experimental Group · 1 Intervention: Selene · Intervention Types: Device
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Proxima Clinical ResearchUNKNOWN
1 Previous Clinical Trials
66 Total Patients Enrolled
Biostatistical Consulting, Inc.OTHER
2 Previous Clinical Trials
240 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
41 Previous Clinical Trials
78,578 Total Patients Enrolled
5 Trials studying Breast Cancer
2,112 Patients Enrolled for Breast Cancer
Perimeter Medical ImagingLead Sponsor
1 Previous Clinical Trials
173 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be of age 18 years or older.
You are able to understand the nature and purpose of the study and the information that you will receive from participating in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.