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Procedure

PTeye Detection for Primary Hyperparathyroidism Surgery

N/A
Recruiting
Led By Paul Gauger
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
Primary hyperparathyroidism who will be undergoing parathyroid surgery
Must not have
Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
Patients with secondary or tertiary hyperparathyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial will compare the use of an FDA-cleared device called PTeye for identifying parathyroid glands during surgery to a surgeon's detection alone.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves using a detection device rather than a drug, typical side effects are not expected. However, there may be risks associated with potential surgical complications from misidentification of glands.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have ongoing high calcium levels due to parathyroid issues after a failed surgery.
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I have primary hyperparathyroidism and will have surgery for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need a total thyroidectomy due to both parathyroid and thyroid disease.
Select...
I have a condition where my parathyroid glands are overactive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood calcium levels
Parathyroid hormone (PTH) levels
Secondary outcome measures
Average number of minutes taken to identify first parathyroid gland
Average number of minutes taken to identify last parathyroid gland
Duration of Surgery in minutes
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PTeyeExperimental Treatment1 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.
Group II: Standard of CareActive Control1 Intervention
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Primary Hyperparathyroidism (PHPT) is often treated surgically through parathyroidectomy, where the overactive parathyroid glands are removed. The use of Near Infrared Autofluorescence (NIRAF) detection, such as with the PTeye device, aids surgeons in accurately identifying parathyroid glands during surgery. This technology leverages the natural autofluorescence of parathyroid tissue when exposed to near-infrared light, enhancing the precision of gland identification and reducing the risk of inadvertently damaging or leaving behind hyperactive tissue. Accurate identification is crucial for successful surgery, minimizing complications, and ensuring the complete removal of the problematic glands, which is essential for the effective management of PHPT.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,387,202 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,241 Total Patients Enrolled
Vanderbilt UniversityOTHER
707 Previous Clinical Trials
6,143,373 Total Patients Enrolled
~0 spots leftby Aug 2024