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Perfusion with Indocyanine green for Shoulder Replacement Surgery (ICG Trial)
N/A
Waitlist Available
Led By John-Erik Bell, 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 2 hours
Awards & highlights
ICG Trial Summary
This trial is testing a new way to image blood flow during shoulder surgery, in order to improve patient outcomes.
Eligible Conditions
- Shoulder Replacement Surgery
- Shoulder Arthritis
- Shoulder Pain
ICG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 2 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
measurement of change to tendon blood supply during total shoulder arthroplasty
Secondary outcome measures
measurement of change to tendon blood supply using different techniques used in total shoulder arthroplasty
ICG Trial Design
1Treatment groups
Experimental Treatment
Group I: patients requiring a shoulder arthroplastyExperimental 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 FDA approved 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
2,543,329 Total Patients Enrolled
John-Erik Bell, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment open to the public?
"As per clinicaltrials.gov, this study has ceased to accept participants as of December 17th 2021. The trial began recruiting on March 1st 2022 and is now one of 84 other medical trials still looking for patients."
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