Peripheral Arterial DiseaseNCT07786623
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
An observational study of Peripheral Arterial Disease and Chronic Limb-Threatening Ischemia, run by Spectrocor.
Trial summary
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Jul 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A Helsinki University Hospital patient scheduled for a vascular surgical operation.
Who may be able to join
- Adults, age of 18 - 90 years
- Scheduled for peripheral arterial bypass surgery.
- Scheduled for proximal arterial reconstruction.
- Ability and willingness to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
Read the detailed description
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.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Keywords
- tissue oxygenation, cytochrome c oxidase, near-infrared spectroscopy, intraoperative monitoring, medical device
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (1)
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.
Measured: From sensor placement during the operation until discharge from hospital (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectrocor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Maarit Venermo, Professor, Principal investigator, Helsinki University Hospital (HUS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786623
- Sponsor's protocol ID
- SpC Vascular
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Keller A. Noninvasive tissue oximetry for flap monitoring: an initial study. J Reconstr Microsurg. 2007 May;23(4):189-97. doi: 10.1055/s-2007-974655.
PubMed 17530610Keller A. A new diagnostic algorithm for early prediction of vascular compromise in 208 microsurgical flaps using tissue oxygen saturation measurements. Ann Plast Surg. 2009 May;62(5):538-43. doi: 10.1097/SAP.0b013e3181a47ce8.
PubMed 19387157Steele MH. Three-year experience using near infrared spectroscopy tissue oximetry monitoring of free tissue transfers. Ann Plast Surg. 2011 May;66(5):540-5. doi: 10.1097/SAP.0b013e31820909f9.
PubMed 21301288Chen Y, Shen Z, Shao Z, Yu P, Wu J. Free Flap Monitoring Using Near-Infrared Spectroscopy: A Systemic Review. Ann Plast Surg. 2016 May;76(5):590-7. doi: 10.1097/SAP.0000000000000430.
PubMed 25664408Tran PC, DeBrock W, Lester ME, Hartman BC, Socas J, Hassanein AH. The False Positive Rate of Transcutaneous Tissue Oximetry Alarms in Microvascular Breast Reconstruction Rises after 24 Hours. J Reconstr Microsurg. 2021 Jun;37(5):453-557. doi: 10.1055/s-0040-1719048. Epub 2020 Oct 31.
PubMed 33129214Ali J, Cody J, Maldonado Y, Ramakrishna H. Near-Infrared Spectroscopy (NIRS) for Cerebral and Tissue Oximetry: Analysis of Evolving Applications. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2758-2766. doi: 10.1053/j.jvca.2021.07.015. Epub 2021 Jul 10.
PubMed 34362641Schanzer A, Hevelone N, Owens CD, Belkin M, Bandyk DF, Clowes AW, Moneta GL, Conte MS. Technical factors affecting autogenous vein graft failure: observations from a large multicenter trial. J Vasc Surg. 2007 Dec;46(6):1180-90; discussion 1190. doi: 10.1016/j.jvs.2007.08.033.
PubMed 18154993Eiberg JP, Schroeder TV, Vogt KC, Secher NH. Near-infrared spectroscopy during peripheral vascular surgery. Cardiovasc Surg. 1997 Jun;5(3):304-8. doi: 10.1177/096721099700500309.
PubMed 9293366Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.
PubMed 32634565