Safety testing of predicate device for Fecobionics

Study Purpose: We are developing a novel wireless device named Fecobionics for mapping colonic and anorectal neuromuscular function. The purpose of this study is to demonstrate the safety and performance of the device in vivo.

Data Collection: This dataset contains animal recording sheets and histology images from the Control group of our safety study in the canine lower GI tract. Hematoxylin and Eosin (H&E) and immunofluorescence (macrophages and caspase-3) staining were performed to identify inflammation in the tissue from different sections of the colon and anorectum.

Primary Conclusion: All procedures were performed successfully. All animals showed normal food intake and behavior. When compared to the control group, no obvious signs of inflammation were shown in both acute and chronic groups.

Curator's Notes

Experimental Design: Six male Mongrel dogs, weighing 25 kg had the predicate device (THD SensyProbe) trans-anally inserted into rectum, then inflated at 20 ml and extracted after 6 mins. The dogs were divided into two groups: The acute group in which the animals were euthanized immediately after the removal of the device, and the chronic group in which the animals were terminated after 2 weeks (N=3 of each). Tissue from different sections of the colon and anorectum were collected after the animals were euthanized. HE and immunofluorescence (macrophages and caspase-3) staining were performed to identify inflammation.

Completeness This dataset is a part of the larger study: "Safety Study of Wireless Fecobionics Device" related dataset: N:dataset:60739e5f-5210-4d04-935d-9f2645b3977f

Subjects & Samples: Six male Mongrel dogs weighing about 25 kg, age 6-8 months were used in the study.

Primary vs derivative data: Data in the primary folder is divided by the subject identification. A pdf file with a detailed data collection sheet is provided for each subject. Each subject folder contains microscopic images of rectum and anus tissue sections stained with: 1). Hematoxylin and Eosin (H&E) Staining 10X microscopic images; 2). expressions of macrophage visualized with Anti-macrophage (red), mucosa staining (green), nuclear counterstain (blue) 20X microscopic images; 3). Expression of caspase-3 visualized with Anti-caspase3 (red), mucosa staining (green), nuclear counterstain (blue) 20X microscopic images.

Image data in the derivative folder (JPEG2000 and OME-TIFF) was derived from primary images (.tif). Each pair of images were merged into multichannel channel images derived from TIFs for each channel (red, blue, and green found in the SOURCE folder).

Tif images were converted with no compression to JPEG2000 (.jp2) by MBF Bioscience for web streaming and visualization on the SPARC Data Portal. Tif images were also converted with lossless compression to OME-TIFF (.tif) by MBF Bioscience. Hematoxylin and eosin image data (JPEG2000 and OME-TIFF) were derived from primary images (.JPG). JPEG images were converted with 20:1 compression to JPEG2000 (.jp2) by MBF Bioscience for web streaming and visualization on the SPARC Data Portal. JPEG images were also converted with lossless compression to OME-TIFF (.tif) by MBF Bioscience.