In 2001, the Cecchi Ltd. has absorbed the company Prodotec srl, which had among its commercial activities the design and production biomedical instrumentation production, inheriting all its know-how and expertise.

Bilitec 2000

The main product is Bilitec 2000, an optical fibre sensor for the detection of bile-containing bilitec EBNeuro-1entero-gastric and gastroesophageal refluxes.  The working principle of the sensor of bile-containing reflux in the gastroesophageal apparatus is based on the detection of the presence of bilirubin, the main biliary pigment. The method was patented by CNR [1], and Prodotec srl, which obtained its exclusive license of the patent, sustained the cost of the extension of the rights at European [2] and American [3] level.

Bilitec 2000 device was initially marketed by the Swedish company Synectics Medical and American multinational Medtronic. subsequently by the American multinational Medtronic. In 2004, Medtronic left the market sector of the instrumentation and devices for the gastroesophageal apparatus and after a period of stalemate since the end of 2010 the device is marketed by EBNeuro.

The method of detection bile-containing reflux in the gastro-oesophageal apparatus is based on the detection of the presence of bilirubin, the main biliary pigment. Notwithstanding the complexity of the optical behaviour of the bile and of bilirubin, it is possible to assert that bilirubin is a good marker for the detection of bile. The measurement is performed by means of the insertion of an optical fibre bundle into the stomach (or oesophagus). The bundle is connected with an optoelectronic unit capable of sending an optical radiation at two different wavelengths to an optical probe positioned at the end of the fibre bundle; the optical fibre probe is actually a miniaturized spectrophotometric cell, of 3 mm external diameter.

One wavelength is the characteristic absorption wavelength of bilirubin (470 nm) and the other one is utilised as reference. Bilirubin is only used as a marker, in order to measure the exposure time of the stomach/oesophagus mucosa to the materials contained in the biliary reflux. This should be considered the clinically-relevant parameter measured with the sensor.

Bile-containing reflux can take place from the duodenum into the stomach and from the stomach into the oesophagus. They are considered contributing factors to the development of several pathological conditions such as gastric ulcer, “chemical” gastritis, upper dyspeptic syndromes, and severe oesophagitis. Under certain conditions, the enterogastric reflux may also increase the risk of gastric cancer.

After its conception, four clinical validations were carried out by four different research groups:

– Clinica Chirurgica 3, University of Florence, Florence, Italy in collaboration with IROE [4];

– Division of Gastroenterology, University of Alabama, Birmingham, Alabama, USA [5];

– Department of Surgery, Technische Universität München, Klinikum Rechts der Isar, Munich, Germany [6];

– Department of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia [7].

The possibility of measuring bile-containing reflux directly measuring the presence of bile represented a winning aspect in comparison with the traditional techniques (pH-metry, cholescintigraphy, bile acid quantification in aspirates and impedentiometry). With the use of the optical fibre sensor, which is truly portable and capable of continuous monitoring, it has been possible to detect bile-containing refluxes correctly for 24-hours, by adopting the same procedure utilised in pH-metry, a routine diagnostic test used by physicians since the 1980s for the analysis of gastro-oesophageal reflux.

[1] R.Falciai, A.M.Scheggi, F.Baldini, P.Bechi, “Metodo di rilevamento del reflusso enterogastrico ed attrezzatura per l’attuazione di detto metodo”, Brev.It. n. 0001213864 released on 05/01/1990

[2] R.Falciai, A.M.Scheggi, F.Baldini, P.Bechi, “Method of detecting enterogastric reflux and apparatus for the implementation of this method”, European Patent number 0323816B1 (6-11-91)

[3] R.Falciai, A.M.Scheggi, F.Baldini, P.Bechi, “Method of detecting enterogastric reflux”, USA Patent Number US 4,976,265 (11-12-1990)

[4] Bechi P, Pucciani F, Baldini F, Cosi F, Falciai R, Mazzanti R, Castagnoli A, Passeri A, Boscherini S (1993) Dig Dis Sci 38: 1297–1306

[5] Vaezi MF, Lacamera RG, Richter JE (1994) Am J Physiol 267: G1050–G1057

[6] Stipa F, Stein HJ, Feussner H, Kraemer S, Siewert JR (1997) Dis Esophagus 10:24–28

[7] Barrett MW, Myers JC, Watson DI, Jamieson GG (2000) Dis Esophagus 13:44–50


Sensor for gastric carbon dioxide

Withinsonda the framework of the European project “Continuous Monitoring of Gastric Carbon Dioxide with Optical Fibres – contract  n.° SMT4-CT96-2064” (1996-2000), Prodotec developed a prototype for the detection of gastric carbon dioxide was developed and clinically tested on volunteers and intensive care patients. Partners of the project were, besides Prodotec

  • Institute of Applied Physics, CNR, Firenze, Italy
  • Department of Critical Care, University of Firenze, Firenze, Italy
    • Medizinische Universitätsklinik, Karl-Franzens-Universität, Graz, Austria
      • Joanneum Research, Institute of Chemical Process Development and Control, Graz, Austria
  1. Baldini, A. Falai, A.R. De Gaudio, D. Landi, A. Lueger, A. Mencaglia, D. Scherr, W. Trettnak “Continuous monitoring of gastric carbon dioxide with optical fibres”, Sensors and Actuators B, 90, pp.132-138, 2003

Optical sensor for gastric pH

Cecchi obtained the exclusive license of the CNR patent related to an optical fibresonda3 probe and sustained the cost of the extension of the rights at European level [2]. A prototype for the detection of gastric pH is in under development in collaboration with the Institute of Applied Physics of the National Research Council. [see poster “A novel optical probe for pH sensing“].

  1. F.Baldini, C.Trono, “Sonda a Fibra Ottica e sensore di misura utilizzante detta sonda”, Brev.It FI2010A000237 filed on 3 December 2010.
  2. F.Baldini, C.Trono, “Fiber optic probe and measuring sensor using said probe”, European Patent EP 2645931 B1, 7 January 2015.

The method of detection bile-containing reflux in the gastro-oesophageal apparatus is based on the detection of the presence of bilirubin, the main biliary pigment. Notwithstanding the complexity of the optical behaviour of the bile and of bilirubin, it is possible to assert that bilirubin is a good marker for the detection of bile.The measurement is performed by means of the insertion of an optical fibre bundle into the stomach (or oesophagus). The bundle is connected with an optoelectronic unit capable of sending an optical radiation at two different wavelengths to an optical probe positioned at the end of the fibre bundle; the optical fibre probe is actually a miniaturized spectrophotometric cell, of 3 mm external diameter.

sonda2One wavelength is the characteristic absorption wavelength of bilirubin (470 nm) and the other one is utilised as reference. Bilirubin is only used as a marker, in order to measure the exposure time of the stomach/oesophagus mucosa to the materials contained in the biliary reflux. This should be considered the clinically-relevant parameter measured with the sensor.

Bile-containing reflux can take place from the duodenum into the stomach and from the stomach into the oesophagus. They are considered contributing factors to the development of several pathological conditions such as gastric ulcer, “chemical” gastritis, upper dyspeptic syndromes, and severe oesophagitis. Under certain conditions, the enterogastric reflux may also increase the risk of gastric cancer.

After its conception, four clinical validations were carried out by four different research groups:

– Clinica Chirurgica 3, University of Florence, Florence, Italy in collaboration with IROE [1];

– Division of Gastroenterology, University of Alabama, Birmingham, Alabama, USA [2];

– Department of Surgery, Technische Universität München, Klinikum Rechts der Isar, Munich, Germany [3];

– Department of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia [4].

The possibility of measuring bile-containing reflux directly measuring the presence of bile represented a winning aspect in comparison with the traditional techniques (pH-metry, cholescintigraphy, bile acid quantification in aspirates and impedentiometry). With the use of the optical fibre sensor, which is truly portable and capable of continuous monitoring, it has been possible to detect bile-containing refluxes correctly for 24-hours, by adopting the same procedure utilised in pH-metry, a routine diagnostic test used by physicians since the 1980s for the analysis of gastro-oesophageal reflux.



  1. Bechi P, Pucciani F, Baldini F, Cosi F, Falciai R, Mazzanti R, Castagnoli A, Passeri A, Boscherini S (1993) Dig Dis Sci 38: 1297–1306
  2. Vaezi MF, Lacamera RG, Richter JE (1994) Am J Physiol 267: G1050–G1057
  3. Stipa F, Stein HJ, Feussner H, Kraemer S, Siewert JR (1997) Dis Esophagus 10:24–28
  4. Barrett MW, Myers JC, Watson DI, Jamieson GG (2000) Dis Esophagus 13:44–50