An interventional study of The Insides System in Intestinal Failure, Enterocutaneous Fistula and Ileostomy - Stoma, sponsored by The Insides Company. Completed at 11 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by The Insides Company · Not applicable, Interventional, and Treatment
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas. The device system functions simply to return the output from a fistula back into the distal limb of the intestine.
The development of enterocutaneous fistulas are devastating consequences of surgery or surgical diseases. They cause excessive fluid and nutrient losses from the gut resulting in severe dehydration and intestinal failure mandating invasive medical therapies to improve survival. These disorders inflict a vast burden of suffering, morbidity, and mortality on patients, while extracting enormous per-patient resources from healthcare systems. Parenteral nutrition is often required, meaning prolonged hospital stay, an attendant risk of line sepsis, venous damage and thrombosis, liver impairment, and death.
There is a pressing demand for breakthrough technologies that can restore lost fluids and nutrients to the body in patients affected by enterocutaneous fistulas in order to reverse intestinal failure, eliminate the need for parenteral nutrition, prevent dehydration and renal injury, allow safe care in the community, enable chemotherapy completion, and restore quality of life.
Exclusion Criteria:
Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN
Device: The Insides System
Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines
Novel pump designed to return effluent from the ostomy bag to the distal gut
Efficacy - the proportion of subjects who achieve a 50% reduction in total caloric intake obtained from parenteral nutrition measured at 30 days post randomization compared to baseline.
Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition
Time frame: 30 days post randomization
Efficacy - Between group comparison of the time to reduction in the use of PN
Between group comparison of the time to reduction of parenteral nutrition measured in days
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to discontinuation in the use of PN
Between group comparison of the time to discontinuation in the use of PN
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids
Between group comparison of the time to reduction in the use of other parenteral support fluids
Time frame: 30 and 60 days
Safety - Between group comparison of the incidence of serious adverse events
Between group comparison of the incidence of serious adverse events such as dehydration, metabolic disarray, failure to complete prescribed chemotherapy, IV line complications, fistula complications, device related effects
Time frame: 30 and 60 days
Efficacy - Between group comparison of the time to ostomy closure
Between group comparison of the time to surgery for ostomy closure measured in days
Time frame: 30 and 60 days
Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies
Between group comparison of the use of proton pump inhibitors, anti motility agents, histamine receptor antagonists, a2 receptor antagonists, and somatostatins.
Time frame: 30 and 60 days
Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)
Between group comparison of the nutritional risk index (NRI). Nutritional failure risk will be categorized as severe (NRI\<83.5), moderate (NRI 83.5 - 97.5) and low (NRI\>97.5).
Time frame: 30 and 60 days
Safety - Between group comparison of peristomal skin complications
Between group comparison of peristomal skin complications measured by the discoloration, erosion, tissue overgrowth (DET) score as mild, moderate or severe
Time frame: 30 and 60 days
Healthcare Utilization - Between group comparison of length of stay for index hospitalization
Between group comparison of length of stay for index hospitalization measured from the day of randomization to discharge
Time frame: up to 30 days
Healthcare Utilization - Between group comparison of all cause hospitalizations
Between group comparison of all cause hospitalizations measured by the total number of discreet hospitalizations \>24 hours in duration
Time frame: 30 and 60 days
Healthcare Utilization - Between group comparison of hospitalizations due to dehydration
Between group comparison of hospital admissions \>24 hours duration where the primary reason for admission is dehydration
Time frame: 30 and 60 days
Device performance - The overall incidence of device related adverse effects
The overall incidence of device related adverse effects reported in subjects randomized to the device. Effects may include effluent cycling time, device wear, device failure.
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D
Between group comparison of quality of life as measured by the EQ-5D-3L - a survey of the following five health dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and a health thermometer where 0= the worst health you can imagine and 100= the best health you can imagine.
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire
Stoma QoL - This questionnaire consists of 20 questions. An example of a question could be: "I worry that the pouch will loosen." All the questions must be answered on a 4-point scale. The options for answering each question are: 1. Always 2. Sometimes 3. Rarely 4. Not at all
Time frame: 30 and 60 days
Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory
Beck Depression Inventory - a 21 question survey where each question has 4 possible answers scored 0-3. The total score is summed to give an overall level of depression 1-10\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_These ups and downs are considered normal 11-16\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Mild mood disturbance 17-20\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Borderline clinical depression 21-30\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Moderate depression 31-40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Severe depression over 40\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_Extreme depression
Time frame: 30 and 60 days
Plan to share: No
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