NIRAF Detection Technology (+) for Thyroid Cancer

Froedtert Hospital and Medical College of Wisconsin, Milwaukee, WI
Thyroid Cancer+3 More ConditionsNIRAF Detection Technology - Device
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Thyroid Cancer
  • Postoperative Hypoparathyroidism
  • Thyroid Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

3 Primary · 8 Secondary · Reporting Duration: Up to 6 months after total thyroidectomy

Hour 72
Number of nights spent in the hospital after total thyroidectomy
Day 14
Hypocalcemia
Month 6
Hypocalcemia
Immediate (during total thyroidectomy)
Number of auto-transplanted parathyroid glands
Number of frozen sections sent for analysis.
Parathyroid gland
Parathyroid gland
Day 10
Number of inadvertently resected parathyroid glands
Month 6
Calcium
Number of doctor visits/emergency department visits or hospital admissions
Hour 24
Postoperative hypoparathyroidism/hypocalcemia (Immediate)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

NIRAF Detection Technology (-)
1 of 2
NIRAF Detection Technology (+)
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: NIRAF Detection Technology (+) · No Placebo Group · N/A

NIRAF Detection Technology (+)
Device
Experimental Group · 1 Intervention: NIRAF Detection Technology · Intervention Types: Device
NIRAF Detection Technology (-)NoIntervention Group · 1 Intervention: NIRAF Detection Technology (-) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after total thyroidectomy

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
577 Previous Clinical Trials
1,156,123 Total Patients Enrolled
Vanderbilt UniversityOTHER
687 Previous Clinical Trials
6,132,842 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,274 Previous Clinical Trials
41,234,659 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have had a complete thyroidectomy surgery.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.