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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-30

Study Completion Date

2019-06-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perfusion; Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Image surgical area

Intervention Type DEVICE

Image surgical area

Interventions

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Image surgical area

Intervention Type DEVICE

Other Intervention Names

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Questionnaire on ease of use and general opinion

Eligibility Criteria

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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)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes