The Insides System for Chyme Reinfusion
Research type
Research Study
Full title
Pivotal study to evaluate the safety and efficacy of the The Insides System for the treatment of subjects with high output enterocutaneous fistula
IRAS ID
279869
Contact name
Dermot Burke
Contact email
Sponsor organisation
The Insides Company Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Proximal small bowel stomas may result from acute, emergency or rescue surgery due to perforations, gut ischaemia, trauma, inflammatory bowel disease, or physiological instability. These stomas commonly result in intractable high-output losses. Intractable high-output stoma losses may also occur in patients with a shortened remnant gut and enterocutaneous fistulas.
Patients with high-output stomas and fistulas face substantial morbidity due to complications arising from excessive fluid and nutrient losses from the gut. These patients may be dependent on IV fluid and electrolyte therapy, and/or parenteral nutrition (given via a vein), lasting until the time of intestinal adaptation or reversal surgery. This can pose complex and expensive challenges to surgical units.
This is a randomised controlled trial to evaluate the safety and effectiveness of The Insides System in patients with high-output stomas and fistulas. The Insides System is a novel device designed to overcome the problems associated with nutrient and fluid losses from stomas and fistulas, that works by pumping the fluid (known as effluent or chyme) lost from stomas and fistulas back into the lower gut.
This study will be conducted at specialist clinical centres in the UK, EU, and US and enroll up to approximately 40 participants with high-output small bowel enterostomies, or enterocutaneous fistulas. Eligible participants will be randomised to standard of care control or treatment with The Insides System. During the study participants will be evaluated at scheduled visits. Evaluations include physical examinations, use of parenteral nutrition, medication review, blood tests, healthcare utilisation, quality of life questionnaires, stoma output and adverse events. After the 4-week follow-up visit has been performed, and primary endpoint data have been collected, all patients will be seen monthly until 30 days post enterostomy closure or 60 days following the primary endpoint. The time period for all participants to complete this study will be approximately 12 months.
REC name
London - Surrey Research Ethics Committee
REC reference
20/LO/1211
Date of REC Opinion
15 Apr 2021
REC opinion
Further Information Favourable Opinion