Spectroscopic Assessment of Tissue Oxyg… | Clinical Trial

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Ischemia Vascular Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Tissue Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults, age of 18 - 90 years
Scheduled for peripheral arterial bypass surgery.
Scheduled for proximal arterial reconstruction.
Ability and willingness to provide informed consent.

Exclusion criteria

Inability to provide informed consent
Considered a vulnerable person according to the Finnish Medical Research Act (488/1999), Chapter 2, Sections 7, 9, and 10, including retarded persons, pregnant women, nursing mothers, prisoners, and forensic patients.
A known history of severe allergic reaction to nickel.

Treatment and study plan

Primary outcomes

Observe changes in skeletal muscle tissue oxygenation

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)

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.

Secondary outcomes

Incidence of adverse events, adverse device effects, and device deficiencies

Time frame: From sensor placement during the operation until discharge from hospital (up to 30 days)

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kalle Kotilahti

CONTACT

[email protected]

+358449016550

Tommi Pätilä, PhD

CONTACT

[email protected]

+358 440130770

Sponsors and collaborators

Lead sponsor

Spectrocor

Industry

Collaborators

Helsinki University Central Hospital

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2031
First posted: Aug 26, 2026
Registry last updated: Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting