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

Christie Medical

Status: Terminated

Conditions: Perfusion; Complications

Treatments: Device: Image surgical area

Study type: Observational

Funder types: Industry

Identifiers

NCT03715270

#E-18-741

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

6 participants in 1 patient group

breast reconstruction surgery patients

Description:

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.

Treatment:

Device: Image surgical area