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NCT06169735 · ClinicalTrials.gov registry record · Phase 4
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
A Phase 4 study of Adenoma and Parathyroid Dysfunction, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 417
- Enrollment target
- 1
- Study location
NCT06169735: Recruiting Phase 4 study of Adenoma and Parathyroid Dysfunction, sponsored by University of Alabama at Birmingham.
NCT06169735 is a Phase 4 study of Adenoma and Parathyroid Dysfunction that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 417 participants, below the 643-participant average among 6 other Adenoma trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06169735, a Phase 4 study of Adenoma and Parathyroid Dysfunction, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 417 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.
Primary Outcome
Measuring the percentage of the number of glands per participant that emit fluorescence. ICG Administration: All enrolled patients with scheduled thyroidectomy or parathyroidectomy will receive a standard cervical incision that afford access to either side of neck. Following sufficient exposure of thyroid, 25 mg of indocyanine green (ICG), reconstituted in 10 ml of sterile water, will be administered intravenously. A dosage of 1 ml of this solution will be injected into a peripheral IV line, fo
Conditions Studied
Interventions
- DRUG Indocyanine green
- DEVICE SPY Portable Handheld Imaging
Study Locations (1)
Alabama
- UAB Callahan Eye - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2024-04-11 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 4 |
What NCT06169735 shows while recruiting
NCT06169735 is an interventional study that assigns participants to a tested intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 643-participant average among 6 other Adenoma trials with a reported enrollment target (35% lower).
The record links to 2 conditions, with Adenoma appearing as the primary indexed condition, and to 2 interventions - of which Indocyanine green is the first listed.
NCT06169735 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06169735 about?
NCT06169735 is a clinical study titled "Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation". The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.
What is the current status of trial NCT06169735?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 417 participants. The study started on 2024-04-11. Estimated completion is 2026-05-01.
What conditions does trial NCT06169735 study?
This clinical trial studies the following conditions: Adenoma, Parathyroid Dysfunction.
What interventions are being tested in trial NCT06169735?
The interventions under investigation include: Indocyanine green (DRUG), SPY Portable Handheld Imaging (DEVICE).
Who is sponsoring clinical trial NCT06169735?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06169735 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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