NCT06899113 Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
| NCT ID | NCT06899113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MIMOSA Diagnostics Inc. |
| Condition | Vascular Disease, Peripheral |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-05-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment. The main questions it aims to answer are: * Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms? * Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage? * Is the MIMOSA Pro able to measure vascular status more often than other modalities? Participants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 and older * Patient is undergoing an ABI test. * Patient recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms) * Patients who can be followed by the same investigating team for the whole period of their participation in the study. Exclusion Criteria: * Patients who are participating in another clinical study for ulcer management * Patients who are unable to understand the aims of the study and not able to provide informed consent * Receiving radiation to the extremity * Active charcot joints
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06899113 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vascular Disease, Peripheral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06899113 currently recruiting?
Yes, NCT06899113 is actively recruiting participants. Contact the research team at aoropallo@northwell.edu for enrollment information.
Where is the NCT06899113 trial being conducted?
This trial is being conducted at Lake Success, United States.
Who is sponsoring the NCT06899113 clinical trial?
NCT06899113 is sponsored by MIMOSA Diagnostics Inc.. The trial plans to enroll 60 participants.