Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 5, 2020

Primary Completion Date

May 2, 2024

Study Completion Date

May 2, 2024

Conditions
Hypoparathyroidism
Interventions
DRUG

Indocyanine Green near infrared fluorescence imaging

ICG-NIRF was performed using the Quest Spectrum Platform 2.0. The camera lens was positioned at a fixed distance of 30 cm to the wound bed, at a perpendicular angle, with the gain set at 22.5 decibels (dB) and an exposure time of 50 milliseconds (ms). ICG was dissolved in sterile water at a concentration of 2.5 mg/mL as recommended by the manufacturer (Verdye). 1.5 mg of ICG per liter of circulating blood volume was then administered through manual bolus intravenous injection. Blood volume estimation was based on the patient\'s height and weight.

DRUG

Indocyanine Green near infrared fluorescence imaging

"ICG-NIRF was performed using the Quest Spectrum Platform 2.0. The camera lens was positioned at a fixed distance of 30 cm to the wound bed, at a perpendicular angle, with the gain set at 22.5 decibels (dB) and an exposure time of 50 milliseconds (ms). ICG was dissolved in sterile water at a concentration of 0.5 or 2.5 mg/mL as recommended by the manufacturer. 1.5 mg of ICG per liter of circulating blood volume was then administered through manual bolus intravenous injection. Blood volume estimation was based on the patients height and weight. Different administration rates (fast: 2s, slow: 15-20s) and a different camera system were tested.~Group 1: Quest Platform 2.0; Fast/Slow; 2.5 mg/mL Group 2: Quest Platform 2.0; Slow/Fast; 2.5 mg/mL Group 3: Quest Platform 2.0; Fast/Fast; 2.5 mg/mL Group 4: Stryker Spy-Elite; Fast/Fast; 2.5 mg/mL Group 5: Quest Platform 2.0; Fast/Fast; 0.5 mg/mL"

Trial Locations (2)

9700RB

University Medical Center Groningen, Groningen

Unknown

Erasmus Medical Center Rotterdam, Rotterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

Leiden University Medical Center

OTHER

lead

University Medical Center Groningen

OTHER

NCT06579430 - Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment | Biotech Hunter | Biotech Hunter