PTeye Detection for Primary Hyperparathyroidism Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called PTeye to determine if it helps surgeons better identify parathyroid glands during surgery for primary hyperparathyroidism. Primary hyperparathyroidism occurs when the parathyroid glands produce too much hormone, causing high calcium levels and other issues. The trial includes two groups: one where surgeons rely on their experience alone, and another where they use the PTeye for guidance. It seeks participants with primary hyperparathyroidism who plan to undergo parathyroid surgery, including those with a history of unsuccessful surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical techniques that could improve outcomes for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the PTeye device is safe for use during parathyroidectomy?
Research has shown that the PTeye device helps locate parathyroid glands during surgeries. In one study, the PTeye accurately identified the parathyroid glands 94.3% of the time, indicating high reliability. The device has also proven safe for use.
Another study examined the device's application in surgeries for conditions like parathyroid adenoma, a non-cancerous tumor in the parathyroid gland. The FDA has cleared the device, confirming its safety for these procedures. However, due to limited data, more information is needed about its long-term safety in rare conditions.
Overall, PTeye appears safe and well-tolerated in surgeries, enhancing the likelihood of successfully locating parathyroid glands without any known major risks.12345Why are researchers excited about this trial?
Researchers are excited about the PTeye technique because it offers a new way to identify parathyroid glands during surgery for primary hyperparathyroidism. Traditional methods rely heavily on the surgeon’s experience and visual cues to locate these glands, which can be tricky and sometimes imprecise. The PTeye introduces an intraoperative tool that uses optical technology to verify if a tissue is a parathyroid gland, potentially increasing the accuracy and safety of the surgery. This innovation could lead to more successful surgeries and better outcomes for patients by minimizing the risk of accidental removal of non-target tissues.
What evidence suggests that the PTeye device is effective for identifying parathyroid glands during surgery?
Research has shown that the PTeye device effectively finds parathyroid glands during surgeries. One study found that PTeye correctly identified parathyroid tissue 94.3% of the time and perfectly ruled out non-parathyroid tissue. Another study demonstrated that surgeries using PTeye were highly successful, with 96.7% proceeding smoothly. In this trial, some participants will undergo surgery using PTeye as an intraoperative tool, while others will receive the standard of care, relying solely on the surgeon's experience. The device significantly improves the detection of parathyroid glands compared to not using it. This suggests that PTeye could make parathyroid surgeries safer and more accurate.35678
Who Is on the Research Team?
Paul Gauger
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for patients with primary hyperparathyroidism needing parathyroid surgery, especially those who had unsuccessful prior surgeries. It excludes pregnant women, patients requiring total thyroidectomy, and those with secondary or tertiary hyperparathyroidism.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo parathyroidectomy (PTx) with or without the use of the PTeye device for parathyroid gland identification
Postoperative Recovery
Participants recover from surgery and are monitored for immediate postoperative outcomes
Follow-up
Participants are monitored for safety, effectiveness, and any complications after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PTeye
Trial Overview
The study tests if identifying parathyroid glands using a device called 'PTeye' during surgery is more effective than surgeon detection alone. The PTeye uses near infrared autofluorescence (NIRAF) to help surgeons find the glands.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Vanderbilt University
Collaborator
Citations
PTeye™ during thyroid and parathyroid procedures - PMC
PTeye™ yielded an overall accuracy of 94.3% with a positive predictive value of 93.0% and a negative predictive value of 100%.
Near-Infrared Autofluorescence for Parathyroid Detection ...
In this study, the surgical sites demonstrated high success rates, with 386 patients (96.7%) having successful procedures. Additionally, 9 ...
The Utility of the PTeye Autofluorescence Detection Device ...
Results: The PTeye-guided surgery group showed significantly higher parathyroid gland identification rates (p < 0.001) and a 20.7 times greater ...
Comparing intraoperative parathyroid identification based ...
Results. PTeye® achieved 92.7% accuracy across 167 patients recruited. Junior surgeons (<5 years of experience) were found to have lower confidence in ...
Assessment of PTeye™ versus FLUOBEAM® LX for ...
Regarding identification times, PTeye™ confirmed parathyroid tissue existence in less than 1 min in 13 cases (65%) and in < 3 min in 7 (35%), ...
DEN170056.pdf - accessdata.fda.gov
Due to a small sample size, limited clinical data is available regarding the safety and effectiveness of the PTeye System for rare disease states such as ...
NCT06913296 | PTeye in Parathyroid Adenoma
The aim of the present study is to evaluate the correlation of PTeye autofluorescence device with biochemical data of parathyroid adenoma patients. Official ...
PTeye™ Parathyroid Detection System
The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
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