PTeye Detection for Primary Hyperparathyroidism Surgery

Overseen By Anee Sophia Jackson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Thyroid disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate

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. ^{1 2 3 4 5}

Why 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. ^{3 5 6 7 8}

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

I have ongoing high calcium levels due to parathyroid issues after a failed surgery.

I have primary hyperparathyroidism and will have surgery for it.

Exclusion Criteria

I need a total thyroidectomy due to both parathyroid and thyroid disease.

I have a condition where my parathyroid glands are overactive.

Pregnant women (Patients with positive pregnancy test results will not be included in the study)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo parathyroidectomy (PTx) with or without the use of the PTeye device for parathyroid gland identification

Immediate

1 visit (in-person, surgical procedure)

Postoperative Recovery

Participants recover from surgery and are monitored for immediate postoperative outcomes

0-72 hours

In-hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and any complications after treatment

6 months

Multiple visits (in-person or virtual)

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?

Group I: Standard of Care Experimental Treatment 1 Intervention

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Group II: PTeye Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8319062/

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%.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2836488

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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39679647/

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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961021002804

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 ...

5. link.springer.com link.springer.com/article/10.1007/s13304-025-02334-7

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%), ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN170056.pdf

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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06913296

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 ...

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/ear-nose-throat/parathyroid-detection-equipment/pteye-parathyroid-detection-system.html

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.