drugset / Trial / NCT06939946

Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)

NCT06939946

Phase 1 Terminated 20 enrolled OPTOSURGICAL, LLC Johns Hopkins University · collab
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2023-09-01
Primary completion
2025-08-28
Completion
2025-08-28

Drugs

EvaluationDrugModalityDoseRoute
Background Indocyanine Green Diagnostic / imaging agent 5 mg Intravenous