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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04956523
Other study ID # CIP-003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date March 1, 2022

Study information

Verified date June 2021
Source Pedra Technology, PTE LTD
Contact Jeremy Moyer
Phone 610-509-6727
Email jmoyer@abioclinical.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel easy to use, non-invasive device that can be used in practice to better inform treatment decisions.


Description:

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions. This is a feasibility study to demonstrate the ability of the Xauron system to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease (PAD). The findings of this study are for research purposes and will also be used to help with the future education of physicians about the potential use of the Xauron system. In addition, this early pilot data will be used to help power larger, more definitive studies relating to the intra-procedural use of the Xauron system.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date March 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: 1. The subject is undergoing endovascular intervention for the management of their PAD. 2. The subject is between 40 to 90 years of age. 3. Documented lower limb arterial occlusive or stenotic disease (using ankle-brachial index / pulse volume recording, duplex ultrasound or CT angiogram) within the last 8 weeks. 4. In the opinion of the Investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments. 5. The subject has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Institutional Review Board (IRB) Exclusion Criteria: 1. Subjects on an investigational drug or being treated with an investigational therapeutic device, within 30 days of the study visit, that in the view of the Investigator might interfere with the study outcomes. 2. Presence of a condition that the Investigator considers will compromise the subject's ability to participate in the study. 3. Subjects on renal replacement therapy 4. Signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot. 5. Lack of intact skin, or pathological skin conditions, at the proposed sensor pad positions that may impair or prevent the adherence of medical adhesives in general. 6. Diabetic subjects with a Charcot neuropathic osteoarthropathy

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pedra Technology, PTE LTD

Outcome

Type Measure Description Time frame Safety issue
Primary Integration of Xauron System into clinical workflow - The Investigator will complete a questionnaire assessing that the Xauron system can be integrated within the angiography suite for all subjects observed. To confirm that the Xauron system can be integrated into he angiography suite clinical workflow. Measured at the SOC index procedure
Secondary Relationship between interventional events of procedure and perfusion changed detected but the Xauron System Measure the time from end of an intervention to the zenith or nadir of the subsequent perfusion change Measured at the standard of care (SOC) index procedure
Secondary Relationship of perfusion data from different anatomical locations during procedure Determine the ratio of perfusion in the arm relative to the foot after an intervention Measured at the SOC index procedure
Secondary User feedback from the team in the angiographic suite To obtain user feedback from the team in the angiography suite to improve the user interface between the device and the operators. Measured at the SOC index procedure
Secondary Angiographic images to evaluate and understand perfusion monitoring Collate data and angiographic images/video that may help endovascular teams understand and utilize perfusion monitoring in the angiography suite. Measured at the SOC index procedure
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