Introducing the REINFUSE Trial

The Insides^® Company is a medical technology company focused on the development and commercialisation of novel chyme reinfusion therapy devices for the treatment of intestinal failure. This pivotal trial is to evaluate the safety and efficacy of The Insides^® System in the treatment of subjects with a double enterostomy and/or enterocutaneous fistula and Type 2 intestinal failure.

Study Design

Global, multicenter, prospective, RCT designed to evaluate the safety and efficacy of the investigational device, The Insides System, in adults with double enterostomy (DES) and/or enterocutaneous fistulas (ECF) and Type 2 intestinal failure.

Primary Endpoint

a 50% reduction in total caloric intake obtained from parenteral nutrition (PN) measured at 30 days post randomization compared to baseline.

Study Details

The study period is 8 weeks leading up to the reversal of their DES/ECF. Patients will be enrolled while an inpatient and then likely discharged home to complete the 8 weeks. Once home, patients will need to have weekly blood tests and weekly contact with the study investigator.

Inclusion criteria

If you have patients that fit the inclusion criteria above please ask each patient to complete a short survey on either of the following patient support websites：

www.oley.org/page/Join_A_study/ or www.ostomy.org/take-a-survey/

For further clinician level information on the study please email：info@databean.com

Proximal and distal limbs contained within one stoma bag

Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube

DES/ECF exposed unobstructed efferent/distal limb

DES/ECF exposed unobstructed afferent/proximal limb

Caution：Investigational device. Limited by United States law to investigational use.