EXECUTIVE SUMMARY
The CEDIT assessed the clinical value of Spectros T-Stat™ for the diagnostisof acute intestinal ischemia. This assessment occurred with the development of the first French stroke center named SURVI (Structure d’URgences Vasculaires Intestinales) in Paris.
Technical aspects: This device uses visible light spectroscopy to measure tissue oxygenation. An optical catheter is introduced via the instrument channel of an endoscope during intestinal fibroscopy to measure real time haemoglobin dioxygen saturation (StO2) capillary O2 with a 1.5 mm sensor without touching the intestinal wall.
Regulatory aspects: This device has been granted market access the by Food and Drug Administration in 2004 via a 510k procedure (without indications mentioned) and is CE marked.
Medical aspects: No study using the Stat TM system for diagnosis of acute intestinal ischemia has been retrieved. Studies available assess the device on animals or on humans but, in that case, in other anatomical locations or indications (on children with congenital cardiac malformation or on adults with chronic intestinal ischemia). The results of such studies are in favour of the effectiveness of the device. In the context of the development of SURVI, a prospective cohort study is considered for the assessment of this device in the diagnosis of AII and in the assessment of the quality of revascularization. More than 1.000 patients with AII have been counted in AP-HP hospitals in 2014, but the disease is likely underdiagnosed. Approximately two hundred patients a year could be treated at SURVI.
Health economic aspects: There are no health-economic studies available. The cost of the device is 32.000 euro with a single use kit at 559 euro per patient.
Organizational aspects: The utilization is considered as simple for an expert. It is used in the context of a digestive endoscopy procedure to explore the small intestine and necessarily handled by a specialist. It increases the duration of the endoscopy procedure by 10 minutes.
CEDIT recommendations:
- The CEDIT recommends the use of the T-Stat™ system for the diagnosis of acute intestinal ischemia in the framework of the stroke center SURVI. An assessment and clinical research aiming to evaluate not only the diagnostic performance of the T-Stat™ system but also the efficacy of the clinical process should be put in place. The method proposed by Dr; Corcos is likely to answer the questions raised.
- The CEDIT recommends Dr Olivier CORCOS, responsible of the Stroke Center SURVIin Paris Nord Val-de-Seine, to make a submission to the “one-stop shop innovation mechanism”1, to obtain funding for a clinical trial with this device.
- In parallel the CEDIT recommends Dr Olivier Corcos to submit a letter of intention within the framework of the PHRC process2.
- The CEDIT does not recommend widespread use of this technology due to the specific nature of the patient care in AII and the lack of evidence of its efficacy in the diagnosis of AII. This position will have to be re-evaluated based on the observed results.
