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Procedure

NIRAF Detection for Thyroid Surgery

N/A
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of surgery
Awards & highlights

Study Summary

This trial compares using a device to detect parathyroid glands during thyroid surgery and whether it improves patient outcomes.

Who is the study for?
This trial is for patients who are set to undergo a complete thyroid removal surgery, with or without lymph node dissection. It's not for those who only need part of their thyroid removed, have parathyroid disease, or find an enlarged parathyroid during surgery.Check my eligibility
What is being tested?
The study tests NIRAF Detection Technology using the 'Parathyroid Eye (PTeye)' device to see if it helps surgeons better identify parathyroid glands during total thyroidectomy compared to surgeries where this technology isn't used.See study design
What are the potential side effects?
Since the intervention involves a detection device rather than a drug, traditional side effects aren't applicable. However, there may be risks associated with potential misidentification of glands leading to surgical complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate (during total thyroidectomy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate (during total thyroidectomy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative hypoparathyroidism/hypocalcemia (Immediate)
Hypocalcemia
Hypocalcemia
Secondary outcome measures
Calcium
Number of auto-transplanted parathyroid glands
Number of doctor visits/emergency department visits or hospital admissions
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NIRAF Detection Technology (+)Experimental Treatment1 Intervention
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
Group II: NIRAF Detection Technology (-)Active Control1 Intervention
Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIRAF Detection Technology
2020
N/A
~160

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,503 Total Patients Enrolled
Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,143,267 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,561 Total Patients Enrolled

Media Library

NIRAF Detection Technology (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05579782 — N/A
Thyroid Cancer Research Study Groups: NIRAF Detection Technology (+), NIRAF Detection Technology (-)
Thyroid Cancer Clinical Trial 2023: NIRAF Detection Technology Highlights & Side Effects. Trial Name: NCT05579782 — N/A
NIRAF Detection Technology (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579782 — N/A

Frequently Asked Questions

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

To what extent has the patient population grown since the beginning of this medical experiment?

"Indeed, the information posted on clinicaltrials.gov reveals that this trial is looking for additional participants as of October 11th 2022. The initial post date was 5th of October and only 60 patients are required from a single site."

Answered by AI

Are there any vacancies for participation in this experiment?

"The clinicaltrials.gov website confirms that this investigation is actively recruiting patients, with its first posting taking place on October 5th 2022 and the most recent update being made on October 11th of the same year."

Answered by AI

Can those under the age of 40 participate in this research project?

"This clinical research project only accepts participants aged 18 to 99. For people below the age of majority, there are 30 separate trials and for those over 65 years old, 229 different studies have been identified."

Answered by AI

Who is the ideal demographic for enrolling in this experiment?

"This clinical trial is seeking around sixty individuals aged 18 to 99 with thyroid adenoma. The ideal participants should have been subject to a total thyroidectomy, or had one previously and still possess an intact gland. Furthermore, all recruits must be eligible for completion of their prior neck exploration procedure."

Answered by AI

What is the ultimate goal of this investigation?

"The primary purpose of the trial is to assess postoperative hypoparathyroidism/hypocalcemia within 5-14 days after total thyroidectomy. Secondary aims include evaluations on the number of nights spent in hospital for recovery, auto-transplanted parathyroid glands, and overall number of identified parathyroid glands (with nude eye + NIRAF in experimental group; with naked eye alone in control)."

Answered by AI
~11 spots leftby Jul 2024