Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
31 October 2022 |
Main ID: |
NCT02680067 |
Date of registration:
|
07/12/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
NIR Fluorescence Imaging of Lymphatic Transport Using ICG
NIR-ICG |
Scientific title:
|
Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green |
Date of first enrolment:
|
December 8, 2015 |
Target sample size:
|
23 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02680067 |
Study type:
|
Interventional |
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
United States
| | | | | | | |
Contacts
|
Name:
|
Christopher Ritchlin, MD/MPH |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University of Rochester |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Ability to provide written informed consent
- Subjects can be either gender but must be at least 18 years old.
- Rheumatoid arthritis subjects may fulfill 2010 American College of Rheumatology
criteria.
- Active rheumatoid arthritis subjects, with at least 2 tender or swollen joints.
- Subjects participating in the clearance arm of the study must not have ICG injections
for at least 10 weeks.
Exclusion Criteria:
- Individuals with active systemic disorders or inflammatory conditions other than
rheumatoid arthritis, (such as chronic infections with hepatitis B, hepatitis C or
HIV) that would confound the study results.
- Known sensitivity to iodine because of residual iodide in Indocyanine Green
- Pregnant women should not participate.
Age minimum:
18 Years
Age maximum:
89 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid Arthritis
|
Intervention(s)
|
Device: MultiSpectral Imaging System
|
Drug: Indocyanine Green
|
Primary Outcome(s)
|
Contraction Rate
[Time Frame: 36 months]
|
Secondary Outcome(s)
|
Lymphatic Pressure
[Time Frame: 36 months]
|
Secondary ID(s)
|
RSRB 54038
|
R01AR056702
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|