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Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Sponsor: OPTOSURGICAL, LLC
Summary
It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. This can lead to complications such as hypocalcemia (low calcium level) requiring treatment and sometimes lead to longer hospital stay. This study is designed to test a new method (a non-invasive hand-held imaging device) to assist surgeons in identifying the parathyroid glands, in order to decrease the rate of post-operative complication.
Official title: Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2023-09-01
Completion Date
2025-08-28
Last Updated
2026-09-22
Healthy Volunteers
No
Interventions
Parathyroid auto-fluorescence imaging
All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.
Indocyanine green
For a select group of patients when deemed necessary by the surgeon, and when one or more parathyroid gland appear to be de vascularized ICG will be administered, A dosage of 5 mg will be injected into a peripheral IV line, followed by fluorescence imaging to determine the perfusion status of the gland.
Locations (1)
Johns Hopkins Hospital
Baltimore, Maryland, United States