← Back to Search

NIRAF Detection with PTeye for Thyroid 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
Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland)
Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours after surgery
Awards & highlights

Study Summary

This trial will compare the use of a near infrared autofluorescence camera to identify parathyroid glands during total thyroidectomy surgery.

Who is the study for?
This trial is for patients with thyroid disease scheduled for total thyroidectomy, including those who've had prior neck surgery but still have an intact thyroid. It's not open to pregnant women, those with both parathyroid and thyroid diseases, or if only part of the thyroid is being removed.Check my eligibility
What is being tested?
The study tests whether using a device called 'Parathyroid Eye (PTeye)' to detect near infrared autofluorescence (NIRAF) helps surgeons better identify parathyroid glands during complete removal of the thyroid gland compared to surgeon's detection alone.See study design
What are the potential side effects?
Since PTeye is a diagnostic tool rather than a drug, it may not have direct side effects. However, its use could affect surgical outcomes like accidental damage or preservation of parathyroid glands.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have thyroid disease and will have my entire thyroid removed.
Select...
I have ongoing thyroid issues and will have more thyroid surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours after surgery 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
Blood parathyroid hormone (PTH) levels
Secondary outcome measures
Duration in minutes of surgery
Duration of calcium and/or Vitamin D supplementation
Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery
+9 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 total thyroidectomy procedure.
Group II: Standard of CareActive Control1 Intervention
The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,675 Total Patients Enrolled
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,142,809 Total Patients Enrolled
University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,364,962 Total Patients Enrolled

Frequently Asked Questions

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

What is the current enrollment tally of participants for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial opened for recruitment on December 1st 2021 and was updated lastly on January 5th 2022. The study requires 160 individuals from a single site to take part in it."

Answered by AI

Are there still opportunities to join this clinical investigation?

"According to the details posted on clinicaltrials.gov, this trial is still enrolling participants; it was initially listed in December of 2021 and last updated at the start of January 2022."

Answered by AI
~20 spots leftby Aug 2024