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Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device (Presygen™)

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ClinicalTrials.gov Identifier: NCT03715270
Recruitment Status : Terminated (Sponsor decision to end study.)
First Posted : October 23, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Christie Medical Holdings, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Perfusion; Complications Device: Image surgical area

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.

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Non-randomized, Non-blinded, Convenience Sample to Evaluate the Surgical Imaging System
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: Image surgical area
Image surgical area
Other Name: Questionnaire on ease of use and general opinion


Outcome Measures
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Primary Outcome Measures :
  1. Photographic, electronic and descriptive comparative analysis of superficial tissue oxygen saturation using Presygen™/si-1 for breast reconstruction subjects. [ Time Frame: 24 hours. ]
    Quantitative measures of tissue oxygen saturation for discrete locations on superficial tissue.


Secondary Outcome Measures :
  1. Quantitative survey providing surgeon assessment of work station during procedure. [ Time Frame: 24 hours ]
    completion of basic questionnaire


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing breast reconstruction surgery and meet the inclusion and exclusion criteria.
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715270


Locations
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United States, New Jersey
Englewood Hospital and Medical Cetner
Englewood, New Jersey, United States, 07631
Sponsors and Collaborators
Christie Medical Holdings, Inc.
More Information
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Publications of Results:

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Responsible Party: Christie Medical Holdings, Inc.
ClinicalTrials.gov Identifier: NCT03715270    
Other Study ID Numbers: #E-18-741
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes