Source：The Insides Company Limited
On：26 October 2026
Organisation：The Insides Company Limited, Royal Brisbane and Women’s Hospital, Northern Care Alliance NHS Foundation Trust, Nottingham University Hospitals NHS Trust, London Northwest University Healthcare NHS Trust, University Hospital Southampton NHS Foundation Trust, Newcastle Hospitals NHS Foundation Trust, Royal Devon University Healthcare NHS Foundation Trust, University of Nebraska Medical Center, University of Miami Health System, University of Illinois Chicago, University of Florida, Henry Ford Health, Department of Medicine, University of Otago, Leeds Teaching Hospitals NHS Trust.
REINFUSE, the first RCT of device-assisted chyme reinfusion in type 2 intestinal failure, is published in BJS Open - the strongest evidence to date that The Insides System can free patients from long-term intravenous feeding.
Auckland, New Zealand, 26 October 2026 - The Insides Company today announced the publication in BJS Open of REINFUSE, the first randomised controlled trial of device-assisted chyme reinfusion therapy (CRT). The trial shows that CRT using The Insides System enabled many patients with type 2 intestinal failure (T2IF) to reduce, and in many cases completely stop, parenteral nutrition (PN) - the intravenous feeding on which they depend.
The problem. T2IF from a double enterostomy (DES) or enterocutaneous fistula (ECF) forces patients to rely on long-term PN through a central venous catheter, carrying risks of bloodstream infection, venous thrombosis and liver disease, with home PN costing up to €85,000 per patient per year. CRT returns the chyme collected from the upstream stoma into the downstream bowel, re-engaging the gut to absorb fluid and nutrients. The Insides System was designed to make CRT quick, easy, clean, safe, and cost effective.
The trial. REINFUSE was a multicentre, open-label RCT across 12 centres in the UK and USA. Of 44 patients assessed, 39 were randomised 2:1 to CRT plus standard care (26) or standard care alone (13) and followed for 60 days. The primary endpoint was a ≥50% reduction in PN calories at Day 30 (significance threshold p<0.025, adjusted for a planned interim analysis).
Key results:
“I am delighted to see the REINFUSE study come to fruition. The results will hopefully encourage clinicians who treat these difficult problems, to enable patients to take a bigger role in their own recovery,” said Professor Dermot Burke, Consultant General and Colorectal Surgeon, Leeds Teaching Hospitals NHS Trust.
Professor David Mercer, Director, Intestinal Rehabilitation Program, University of Nebraska Medical Centre commented, “The data from the REINFUSE trial is very exciting as it demonstrates (again) that chyme reinfusion using the Insides system has significant advantages for patients in both fluid loss and need for intravenous support. It offers a vastly superior technical advantage over typically burdensome methods for chyme reinfusion that may be attempted presently. We look forward to adopting it widely in our intestinal failure patients in the future.”
About The Insides Company and System. The Insides Company is a leading provider of medical devices that perform chyme reinfusion for intestinal failure, intestinal rehabilitation, colorectal function testing, and intestinal continuity maintenance. The Insides System performs device-assisted CRT via a custom distal catheter in the downstream limb, a small impeller pump within the stoma appliance, and an external battery-operated driver that returns chyme to the distal bowel.
Media contact:
Article: BJS Open, Volume 10, Issue 5, October 2026, zrag158.
https://doi.org/10.1093/bjsopen/zrag158. Registration: NCT04577456.
Disclaimer: Availability, indications, regulatory status and reimbursement of The Insides System vary by jurisdiction. Findings are from a single RCT and do not constitute a claim of regulatory approval or reimbursement.
© 2026 The Insides Company. All copyright, design, patent and intellectual property rights existing in our designs and products and in the images, text and design of our website / marketing material are the property of The Insides Company.
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