RECRUITING

Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Observational study. The purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. The goal is to collect information about the efficiency and effectiveness of the EnVisio Surgical Navigation for intraoperative guidance to obtain negative margin on initial specimen. Prospective Patient Study: 200 consecutive patients

Official Title

Prospective Analysis of EnVisio Spatial Intelligence for Soft Tissue Localization and Guided Surgical Excision

Quick Facts

Study Start:2024-08-07
Study Completion:2026-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06572410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient has image identifiable lesion.
  2. * Patient has selected breast conservation therapy IE: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. Neoadjuvant chemotherapy is not an exclusion criterion.
  3. * Patient will be undergoing target tissue localization with the SmartClip
  4. * Patient will be undergoing BCS Breast Conserving Surgery treatment for DCIS or invasive breast cancer with EnVisio ® Navigation System.
  5. * Patient must be age \> or = 18 years.
  6. * Patients unable to provide consent to surgery must have authorized representative provide consent.
  1. * Patients undergoing mastectomy for resection of the targeted lesion.
  2. * Patient is localized with an alternative method.
  3. * Patient that are pregnant.

Contacts and Locations

Study Contact

Jason A Boardman, MD
CONTACT
352-243-2622
jaboardmanmd@hotmail.com

Study Locations (Sites)

Advent Winter Garden
Winter Garden, Florida, 34787
United States

Collaborators and Investigators

Sponsor: Elucent Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2026-02-15

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2026-02-15

Terms related to this study

Additional Relevant MeSH Terms

  • Tumors, Breast