Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery

• All adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Locations
United States
California
University of California, San Francisco
San Francisco
Time Frame
Start Date: 2022-01-10
Completion Date: 2024-11-30
Participants
Target number of participants: 79
Treatments
Experimental: Parathyroid Eye (PTeye)
For patients assigned to the study arm, the surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
No_intervention: Usual Standard of Care
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Authors
Quan-Yang Duh
Sponsors
Leads: University of California, San Francisco
Collaborators: Vanderbilt University Medical Center, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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