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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03715270
Other study ID # #E-18-741
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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