Clinical trial NCT03715270: Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
Official title: Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Perfusion; Complications
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.
timeFrame: 24 hours.
Secondary outcomes:
measure: Quantitative survey providing surgeon assessment of work station during procedure.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Cetner
state: New Jersey
Study officials:
References:
citation: 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.
citation: 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.