An observational study in Flap Ischemia and Hypoxia, 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.
A total of 30 participants aged 18 or older, with a planned plastic surgical reconstructive flap operation, will be recruited in this investigation. The primary purpose is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor peripheral tissue oxygenation perioperatively. The investigation is designed as an open, non-controlled observational study with the primary goal of assessing the devices' ability to monitor and observe tissue oxygenation and safety in routine operation, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is needed in this investigation.
In this study, the SpectroCor Tissue Oxygenation Monitoring is used to observe flap viability during and after plastic surgical reconstruction. SpectroCor sensor is inserted into the reconstructed flap or into the subcutaneous tissue in the distal wound to observe and collect data on tissue oxygenation. During the procedure, the flap tissue undergoes an ischemic period during microsurgical anastomosis, followed by reperfusion upon release of the vascular clamp. During the reconstructive flap surgery, spectroscopic data of tissue oxygenation are collected and compared to the recorded tissue saturation levels and to occurring events, procedures, and clinical parameters.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 30 is below the median of 79 across 277 observational studies indexed under Hypoxia.
Browse Hypoxia studies →Spectrocor is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for plastic surgical reconstructive flap operation in the Helsinki University Central Hospital.
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 flap tissue oxygenation
To observe the changes in flap tissue oxygenation (combined hemoglobin/myoglobin saturation, %) measured by the SpectroCor Monitoring System during the ischemia-reperfusion sequence of microvascular flap reconstruction. Continuous spectroscopic measurement of combined hemoglobin and myoglobin oxygen saturation in the transferred flap tissue, recorded from a SpectroCor Sensor inserted into the flap, with a second sensor placed in subcutaneous tissue of the distal wound. Saturation values are time-stamped against intraoperative events affecting flap perfusion (pedicle division and flap detachment from the donor site, completion of the microvascular anastomosis, release of the vascular clamp and reperfusion, and any anastomotic revision) and compared with paired arterial and venous blood gas samples obtained at the beginning and at the end of the surgery.
Time frame: From sensor placement until sensor removal minutes before completion of surgery (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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