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Fluorescence Arthroscopy for Knee Injuries
N/A
Recruiting
Led By Michael B Sparks, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
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 baseline, up to 20 minutes
Awards & highlights
Study Summary
This trial looked at whether a new way of looking at the knee joint could help doctors understand what is going on with knee pain.
Who is the study for?
This trial is for adults over 18 with a meniscal tear confirmed by MRI or preoperative assessment. It's not suitable for those who are pregnant, breastfeeding, have an iodine allergy, burns, septic arthritis in the joint to be operated on, or if they're unlikely to survive more than 90 days.Check my eligibility
What is being tested?
The study is testing how well dynamic contrast-enhanced fluorescence arthroscopy can show blood flow in knee tissue using a dye called Indocyanine green. This observational study will see if this method is feasible for assessing meniscus vascularity during surgery.See study design
What are the potential side effects?
Potential side effects may include reactions to the Indocyanine green dye used during the procedure such as allergic reactions or skin complications at the site of injection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 20 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of meniscal blood supply using Indocyanine green (ICG)
Secondary outcome measures
Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with a meniscal tear requiring surgeryExperimental Treatment1 Intervention
Patients will be administered Food and Drug Administration (FDA) approved Indocyanine green (ICG) through intravenous injection and imaged by a FDA approved surgical fluorescence imaging device. Both ICG fluorescence and the imaging system have been used for routine clinical practice for many years. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to meniscal perfusion can be captured by an arthroscopic imaging system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perfusion with Indocyanine green
2022
N/A
~10
Find a Location
Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,311 Total Patients Enrolled
1 Trials studying Knee Injuries
260 Patients Enrolled for Knee Injuries
KARL STORZ Endoscopy-America, Inc.Industry Sponsor
11 Previous Clinical Trials
21,443 Total Patients Enrolled
Michael B Sparks, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant or currently breastfeeding.You have burns on your body.Your doctor thinks you have less than 3 months to live.You are allergic to iodine.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with a meniscal tear requiring surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available slots for this current clinical experiment?
"Confirmed by clinicaltrials.gov, this research study is now actively seeking participants after being first made available on December 1st 2022 and updated most recently in January 21st of the same year."
Answered by AI
What is the cap on participant recruitment for this clinical trial?
"Affirmative. According to the existing information on clinicaltrials.gov, this trial is still searching for volunteers; it was first published on December 1st 2022 and most recently modified on January 21st 2022. 30 patients are needed in total from a single medical site."
Answered by AI
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