An observational study in Peripheral Arterial Disease, Peripheral Artery Disease and Arterial Occlusive Diseases, sponsored by Pedra Technology, PTE LTD. Status unknown. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Pedra Technology, PTE LTD · Observational
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.
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.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's planned enrollment of 80 is below the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Pedra Technology, PTE LTD is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a prospective, multi-center, observational, feasibility study to collect tissue perfusion data throughout the duration of a standard of care (SOC) endovascular intervention, alongside live video capture of the angiography utilized during the case. The study will enroll up to 80 subjects between the ages of 40 and 90 who are undergoing endovascular intervention for the management of their PAD. The protocol is designed for sites to enroll approximately half of the subjects with primary "below the knee disease".
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Exclusion Criteria:
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 the angiography suite clinical workflow.
Time frame: Measured at the SOC index procedure
Relationship between interventional events of procedure and perfusion changes detected by Xauron System
Measure the time from end of an intervention to the zenith or nadir of the subsequent perfusion change
Time frame: Measured at the SOC index procedure
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
Time frame: Measured at the SOC index procedure
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.
Time frame: Measured at the SOC index procedure
Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Walking Score.
Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the Walking Score.
Time frame: Measured through 3-month follow-up
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.
Time frame: Measured at the SOC index procedure
Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the Pain Score.
Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the Pain Score.
Time frame: Measured through 3-month follow-up
Relationship between changes in perfusion during intervention and the clinical outcomes of patients using the SF-36 Score
Evaluate the relationship between changes in perfusion during the intervention and the clinical outcomes of the patients in terms of changes in the SF-36 score.
Time frame: Measured through 3-month follow-up
No study locations are listed for this record.
Start is estimated for Mar 2021; primary completion for Nov 2021, 8 months later.
Of 58 industry-sponsored observational studies under Peripheral Arterial Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's planned 8 months is below that.
Counting every sponsor, half of 197 studies reached it within 37 months; a quarter within 23 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Pedra Technology, PTE LTD