Status:
TERMINATED
Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Lead Sponsor:
OPTOSURGICAL, LLC
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Thyroid Disease
Thyroid Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ar...
Detailed Description
In thyroid surgeries, it is often difficult to visually distinguish parathyroid glands (PTGs) from the surrounding anatomical structures in surgeries because of their small size and appearance that is...
Eligibility Criteria
Inclusion
- Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation.
- Plan for surgical resection of pathological PTGs.
- Subject age 18 - 70 yo.
- Subject agreement to participate
Exclusion
- Not eligible for endocrine surgeries
- Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment)
- Subject age younger than 18 yo or older than 70 yo
- Subject refusal to participate
- Subject cognitively impaired and/or unable to provide assent.
- Allergy to indocyanine green and iodine.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06939946
Start Date
September 1 2023
End Date
August 28 2025
Last Update
December 19 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287