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

Stopped early

Conditions studied: Perfusion; Complications

In brief

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.

Key facts

Study ID

NCT03715270

Run by

Christie Medical Holdings, Inc.

People needed

6

Starts

2019-01-30

Expected to finish

2019-06-05

Last updated by the study team

2019-06-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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