Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device (Presygen™)

Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System

This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.

Study Overview

• Status: Terminated
• Conditions: Perfusion; Complications
• Intervention / Treatment: Device: Image surgical area

Detailed Description

Over the last decade, objective ways of measuring tissue oxygen have been introduced into the medical arena and are being used more and more for assessing ischemic events in tissue. Handheld Doppler ultrasound, infrared thermography, polarized spectral imaging, laser Doppler perfusion imaging, and fluorescence imaging have all been used with some degree of success. However, only a few have gained universal acceptance. [1] Multispectral imaging (MSI) which uses near-infrared (NIR) light to measure tissue oxygen levels in superficial tissue is another method that has been successfully used to assess tissue flap health.

The objective of this study is to conduct an evaluation of superficial tissue with Presygen™/si-1 in various patient types for surgical imaging during breast reconstruction. In addition, participating surgeons will complete a structured survey regarding their assessment of Presygen™/si-1 work station during the surgical procedure.

Primary Goal: Evaluation of superficial tissue in various patient types for surgical imaging during breast reconstruction.

Secondary Goal: Surgeon assessment of surgical work station during surgery through a prepared questionnaire.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Cetner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Candidate for surgical intervention with breast reconstruction as part of the surgical plan
• 22 years of age or older;
• Able to understand and provide informed consent with HIPAA authorization.
• Able to read and understand in English.

Exclusion Criteria:

• Subjects who might need a legally-authorized representative
• Subjects who possess diminished mental capabilities
• Conditions that preclude imaging (excessive scarring, tattoos in surgical field, Fitzpatrick Scale VI)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
breast reconstruction surgery patients; Patients will be imaged with imaging device (Presygen™/si-1) during surgical procedure. Image surgical area. Surgical procedure will follow standard of care. No clinical decisions will be made on device readings. A surgeon will complete a survey regarding his assessment of the imaging device.	Device: Image surgical area; Image surgical area; Other Names: Questionnaire on ease of use and general opinion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.	Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.	24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative survey providing surgeon assessment of work station during procedure.	completion of basic questionnaire	24 hours

Collaborators and Investigators

• Sponsor: Christie Medical Holdings, Inc.

Publications and helpful links

General Publications

• Pestana IA, Coan B, Erdmann D, Marcus J, Levin LS, Zenn MR. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009 Apr;123(4):1239-1244. doi: 10.1097/PRS.0b013e31819e67c1.
• Colwell AS, Craft RO. Near-infrared spectroscopy in autologous breast reconstruction. Clin Plast Surg. 2011 Apr;38(2):301-7. doi: 10.1016/j.cps.2011.03.014.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: #E-18-741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes