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

Perfusion; Complications Clinical Trial

— Presygen™  

Official title:

Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03715270
• Other study ID #: #E-18-741
• Status: Terminated
• Start date: January 30, 2019
• Est. completion date: June 5, 2019

Study information

• Verified date: June 2019
• Source: Christie Medical Holdings, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Perfusion; Complications

Intervention

Device:
• Image surgical area
Image surgical area

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Cetner	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Christie Medical Holdings, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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):1239-44. doi: 10.1097/PRS.0b013e31819e67c1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects.	Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.	24 hours.
Secondary	Quantitative survey providing surgeon assessment of work station during procedure.	completion of basic questionnaire	24 hours