- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03294902
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System (IROAD)
September 18, 2020 updated by: Pedra Technology, PTE LTD
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow.
The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment.
Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm.
The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics.
The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console.
The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems.
The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cambridge, United Kingdom, CB2 0QQ
- Addenbrooke's Hospital, Department of Vascular Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The 3 distinct subjects groups are divided as such:
- Critical Limb Ischaemia (CLI) Group with tibial arterial disease: Up to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group.
- Peripheral Artery Disease (PAD) Group with SFA disease: Up to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter.
- PAD-free Group (Healthy Volunteer Group): Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
Description
General Inclusion Criteria:
- The patient is a male or non-pregnant female ≥ 40 to 90 years of age
- The patient is willing to comply with protocol-specified follow-up evaluations
- The patient has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Ethics Committee (EC)
Cohort Specific Inclusion Criteria:
Critical Limb Ischaemia Group Inclusion Criteria:
- The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments.
- Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels.
Peripheral Arterial Disease Group Inclusion Criteria:
- The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments.
- This subject must have a clinical diagnosis of claudication and duplex or CT-confirmed SFA or popliteal artery stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter.
PAD-Free Group Inclusion Criteria:
- The subject is recruited voluntarily
- Absence of peripheral vascular disease determined by questionnaire and clinical review (triphasic signals on hand-held Doppler)
Exclusion Criteria:
- Infusion of vasoactive medications within the past 24 hours
- The presence of a known chronic history of anaemia (i.e. Hb <8g/dL)
- Congestive heart failure defined by NYHA Classification 3 or 4
- The absence of intact skin at suitable measurement sites on the foot.
- The presence of invasive soft tissue infection in the toes spreading into the forefoot.
- The presence of physical impediment to the method of measurements being completed (i.e. absent first two toes, extensive ulceration, excessive oedema, pressure dressings or heavy bandaging, etc.)
- The presence of a non-salvageable foot or a Rutherford 6 wound.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the subject safety or comfort.
- The presence of other conditions, which in the opinion of the Investigator, may compromise the accuracy of the data obtained.
- The patient is a vulnerable or protected adult, or is unable to provide consent.
- The patient is unable to comply with the measurement protocol.
- Pregnant subjects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Critical Limb Ischaemia (CLI) Group with tibial arterial dis
Up to 20, but at least 8 subjects with a Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels.
The treatment of SFA stenoses of less than 70%, as confirmed by duplex or CT, is acceptable in parallel in this group.
|
This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom.
Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group.
Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol.
All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
|
Peripheral Artery Disease (PAD) Group with SFA disease
Up to 20, but at least 8 subjects with a clinical diagnosis of claudication and duplex or CT-confirmed SFA stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter.
|
This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom.
Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group.
Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol.
All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
|
PAD-free group (Healthy Volunteer Group)
Up to 20 subjects with no clinical diagnosis of peripheral vascular disease.
|
This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom.
Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group.
Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol.
All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time Frame: Baseline visit: 30-60 minutes after pad removal
|
This observation assessment is completed by the physician post removal of the adhesive pads.
It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
|
Baseline visit: 30-60 minutes after pad removal
|
During procedure safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time Frame: During procedure visit: 30-60 minutes after pad removal
|
This observation assessment is completed by the physician post removal of the adhesive pads.
It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
|
During procedure visit: 30-60 minutes after pad removal
|
36-hrs post-procedure/ discharge visit safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in ≥ 90% of subjects after removal of the Pedra sensors.
Time Frame: 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
|
This observation assessment is completed by the physician post removal of the adhesive pads.
It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin).
|
36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
August 25, 2017
First Submitted That Met QC Criteria
September 26, 2017
First Posted (Actual)
September 27, 2017
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Pedra Tissue Perfusion Monitor
-
University Hospital Inselspital, BerneTerminated
-
Erzincan UniversityUnknownAnesthesia; Adverse EffectTurkey
-
Major Extremity Trauma Research ConsortiumCompleted
-
Complexa, Inc.Philips Healthcare; Medpace, Inc.; Allegheny Singer Research Institute (also... and other collaboratorsTerminatedPAHUnited States, United Kingdom
-
Assiut UniversityCompletedAwareness, AnesthesiaEgypt
-
Pusan National University HospitalCompletedHealthy | AgingKorea, Republic of
-
Szeged UniversityCompletedHealthy Subjects | COPDHungary
-
British Columbia Cancer AgencyCanadian Institutes of Health Research (CIHR)Terminated
-
Boehringer IngelheimCompleted
-
University Hospital Inselspital, BerneEdwards LifesciencesCompletedVasodilation | Vasoconstriction | Hemodynamics | Cardiac Output, Low | Cardiac Output, HighSwitzerland