An observational study in Circulatory; Change, sponsored by Pedra Technology, PTE LTD. Status unknown. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by Pedra Technology, PTE LTD · Observational
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The Pedra perfusion system will be used to assess changes in perfusion in response to physiological stimuli. It will be compared to other standard diagnostics.
The Pedra perfusion system measures microvascular flow through diffuse speckle contrast analysis. It will be used to assess changes in perfusion in response to a number of physiological stimuli. It will be compared to other standard diagnostics including ankle-brachial index, toe-brachial index and transcutaneous oxygen measurement. Measurements will be undertaken in non-vascular patients as well as those with chronic limb threatening ischaemia.
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.
Patients with palpable pulses and patients with chronic limb threatening ischaemia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CLTI cohort
Non-vascular group
Exclusion Criteria:
CLTI Cohort
Non-vascular Cohort
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort of patients with palpable pulses will be used to test inter- and intra- observer variability for the Pedra system
Device: Pedra
This cohort of patients with palpable pulses will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
Device: Pedra
This cohort of patients with CLTI will assess the ability of Pedra to detect perfusion changes in response to physiologic stimuli.
Device: Pedra
Diffuse speckle contrast analysis perfusion system
The Blood Perfusion Index (unitless number) delta in response to reduction in arterial inflow pressure
The range of change in the Blood Perfusion Index (unitless) in response to physiologic changes in arterial perfusion, in patients with healthy circulation and those with compromised arterial circulation
Time frame: Intra-procedure
Reliability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
The reliability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
Time frame: intra-procedure
Repeatability of Blood Perfusion Index measurement will be assessed on repeated measures by determination of the correlation coefficient
The repeatability of measurement of the Blood Perfusion Index will be measured and compared to standard diagnostics
Time frame: intra-procedure
Sensitivity of Pedra to detect differences in the Blood Perfusion Index between patient subsets
Use of a ROC curve to assess the ability of the Blood Perfusion Index to differentiate between those with healthy circulation and those with arterial disease
Time frame: Intra-procedure
No study locations are listed for this record.
Plan to share: No — No plan to share data
No publications or documents are linked to this record.
Start is estimated for Dec 2020; primary completion for Apr 2021, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Pedra Technology, PTE LTD