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Imaging Dye for Parathyroid Disease

Phase 4
Recruiting
Led By Herbert Chen, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age greater than 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if a special dye can help make thyroid and parathyroid surgery safer and more accurate.

Who is the study for?
This trial is for adults over 18 who need thyroid or parathyroid surgery. It's not suitable for those with allergies to iodine, shellfish, or indocyanine green, nor for pregnant individuals.
What is being tested?
The study tests if using a special dye called indocyanine green and a portable imaging device can help surgeons better identify and protect the parathyroid glands during surgery.
What are the potential side effects?
Potential side effects may include allergic reactions to the indocyanine green dye. However, since this is used externally with imaging equipment, risks are generally low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Parathyroid Glands identified by ICG

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Parathyroid patientsExperimental Treatment2 Interventions
patients who require parathyroid identification and preservation during parathyroid surgery maneuver
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
2016
Completed Phase 4
~1720

Find a Location

Who is running the clinical trial?

Stryker NordicIndustry Sponsor
34 Previous Clinical Trials
3,982 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,443,958 Total Patients Enrolled
Herbert Chen, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
366 Total Patients Enrolled
~139 spots leftby May 2025
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