Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye

NCT03625765 | Withdrawn FDA Device

• 1 other identifier: CASE2118
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures. The participants will be asked to participate in the study if they are scheduled to have a breast reconstruction procedure using a technique that involves transferring abdominal skin and tissues to the affected side of the chest. This technique is known as a breast reconstruction with a Deep Inferior Epigastric Artery Perforator (DIEP) flap. In this pilot study, the investigators are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called "Smart Goggles") as a surgical aid to differentiate between tissue with adequate blood flow and tissue without adequate blood flow by comparing measurements of fluorescence in blood vessels with current technology, the SPY-Elite system. In this study, researchers will test how quickly and accurately the fluorescent dye used to identify adequate blood flow is detected by Smart Goggles compared to the SPY Elite system.

Conditions

Breast Reconstruction

Keywords

Indocyanine green; SmartGoggles

Outcome Measures

Primary Outcomes (1)

• ICG transit time detected by the SmartGoggles and the SPY Elite system.

  The time needed for ICG to first appear in flap after intravenous injection

  At the end of surgery - 1 day

Secondary Outcomes (2)

• Difference in the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests

  At the end of surgery - 1 day

• Difference in square area of perfusion as detected by ICG angiography under the SmartGoggles and SPY Elite systems

  At the end of surgery - 1 day

Study Arms (1)

SmartGoggles

EXPERIMENTAL

The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. Investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nanomolar (nM) concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with optical density (OD) 6 level cut-off. The SmartGoggles is a non-invasive imaging system that does not require contact with patients.

Device: SmartGoggles

Interventions

SmartGoggles DEVICE

the system is wearable and simulates natural binocular human vision, which minimizes the training curve for new users. The wide-field stereoscopic imaging allows clinicians to rapidly determine the extent of lesions and the hand-held microscopy probe assist clinician to visualize the lesions with high resolution.

SmartGoggles

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral DIEP flap breast reconstruction
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Pregnant women
• Patients with severe hepatic insufficiency
• Patients with a history of allergic reactions or know hypersensitivity to ICG and iodide

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Risal Djohan, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: November 22, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

US (1)