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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study 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.

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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,787 Previous Clinical Trials
6,365,374 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,187 Total Patients Enrolled
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still recruitment opportunities for this research endeavor?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study is currently enrolling participants. It was first published in December 2021 and modified most recently in January 2022, with 160 patients anticipated across one research centre."

Answered by AI

What is the current enrolment of participants in this experiment?

"That is correct. According to the information listed on clinicaltrials.gov, this study that began recruitment on December 1, 2021 is still open and currently recruiting patients. It requires 160 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~20 spots leftby Aug 2024