First Clinical Trial in Sweden
B!BBInstruments first product, EndoDrill® GI, has successfully been evaluated at a randomized pilot clinical trial at Skåne University Hospital in Lund, Sweden. The CE-marked device is continuously being improved to reflect design input from users. Follow-up clinical trials are ongoing.
The following abstract was presented at the annual meeting of the Swedish Surgical Society in Örebro, Sweden 2015-08-17
Sampling of submucosal lesions in the gastrointestinal tract through a flexible endoscope is a well-recognized clinical problem. Biopsies provided by the forceps are usually epithelial only and sufficient amount of representative submucosal material is seldom achieved. The standard technique for sampling of submucosal lesions, endoscopic ultra sound guided fine-needle aspiration (EUS-FNA), has few complications, but does not provide tissue biopsies with preserved architecture for histopathological evaluation. To achieve this we constructed a new endoscopic biopsy tool, with a drilling function, and compared it in a prospective randomized study with a standard single-use biopsy forceps in sampling of submucosal lesions.
A total of 10 patients with endoscopically verified submucosal lesions were randomized. The endoscopist selected the position for the first biopsy and used the instrument selected by randomization. After the biopsy was harvested the endoscopist chose the next site for a biopsy and again used the instrument picked by randomization. A total of 6 biopsies, 3 with the forceps and 3 with the drill instrument were collected in every patient.
The drill instrument resulted in larger total size biopsies (mm2), (Mann-Whitney U-test, p=0.048), and larger submucosal part (%) of the biopsies (Mann-Whitney U-test, p=0.003) than the forceps. Two patients were observed because of chest pain and suspicion of bleeding, respectively in 24 hours. No therapeutic measures were necessary to be taken.
In conclusion the new drill instrument for flexible endoscopy can deliver core needle like diagnostic material from submucosal lesions in the upper gastrointestinal tract.