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

Launched by OPTOSURGICAL, LLC · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new hand-held imaging device that helps surgeons identify parathyroid glands during thyroid surgery. The parathyroid glands are small glands located near the thyroid, and sometimes they can be hard to see because they are surrounded by other tissues. If surgeons can’t find them, there’s a risk they might accidentally remove or damage them, which can lead to low calcium levels and longer hospital stays. The goal of this study is to see if this new imaging tool can help reduce these risks and improve patient outcomes.

To participate in this trial, you need to be between 18 and 70 years old and have a thyroid condition that requires surgery. You should also be willing to take part in the study. However, if you have certain conditions, like allergies to specific dyes used in imaging or if you are not eligible for endocrine surgeries, you won't be able to join. If you do participate, you can expect to have your surgery with the assistance of this new imaging device, which aims to make the process safer and more effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.