Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device

Terminated

• Conditions: Perfusion; Complications
• Interventions: Device: Image surgical area

• Registration Number: NCT03715270
• Lead Sponsor: Christie Medical Holdings, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-23
• Study Start: 2019-01-30
• Status Verified: 2019-06
• Primary Completion: 2019-06-05
• Study Completion: 2019-06-05
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
breast reconstruction surgery patients	Image surgical area	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quantitative survey providing surgeon assessment of work station during procedure.	24 hours	completion of basic questionnaire

Trial Locations

Locations (1)

Englewood Hospital and Medical Cetner; 🇺🇸 Englewood, New Jersey, United States