An observational study in Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia and Ischemia Vascular, sponsored by Spectrocor. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Spectrocor · Observational
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
A total of 30 participants, aged 18 or older, undergoing planned elective primary vascular surgery will be recruited in this investigation to assess the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to monitor peripheral tissue oxygenation perioperatively. The investigation is designed as an open, uncontrolled observational study in which the primary goal is to assess the Monitor's ability, in combination with the Sensor, to monitor tissue oxygenation and safety in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control participants are needed in this investigation.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 30 is below the median of 111 across 102 observational studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Spectrocor is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Compared within Chronic Limb-Threatening Ischemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
A Helsinki University Hospital patient scheduled for a vascular surgical operation.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observe changes in skeletal muscle tissue oxygenation
To observe the changes in skeletal muscle tissue oxygenation (combined hemoglobin/myoglobin saturation, %) measured by the SpectroCor Monitoring System during arterial clamping and restoration of limb perfusion. Continuous spectroscopic measurement of combined hemoglobin and myoglobin oxygen saturation in skeletal muscle of the operated limb, recorded from a SpectroCor Sensor placed in the distal wound before any arterial clamping. Saturation values are time-stamped against intraoperative events affecting limb perfusion (proximal arterial clamping, unclamping, graft revision) and compared with paired arterial and venous blood gas samples obtained before clamping and after restoration of blood flow.
Time frame: From sensor placement prior to arterial clamping until restoration of limb blood circulation and completion of vascular reconstruction quality control (intraoperative period, approximately 2-6 hours)
Incidence of adverse events, adverse device effects, and device deficiencies
Number and proportion of participants experiencing at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), serious adverse device effect (SADE), or unanticipated serious adverse device effect (USADE), and the number of device deficiencies (DD) recorded. Events are recorded from the time of sensor placement until discharge from hospital and assessed for causal relationship to the investigational device by the investigator. Anticipated device-related events include topical bleeding at the sensor attachment site, local tissue reaction associated with tissue glue fixation, and local infection at the insertion site.
Time frame: From sensor placement during the operation until discharge from hospital (up to 30 days)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. Participant consent and the approved Clinical Investigation Plan do not cover secondary sharing of individual-level data, and the sponsor's obligations under Regulation (EU) 2016/679 (GDPR) preclude onward transfer without a valid legal basis. Aggregate results will be published in accordance with the publication policy and made publicly available in EUDAMED, and the clinical investigation report will be submitted to the competent authority within one year of the end of the investigation.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia →