Chyme Reinfusion for Type 2 Intestinal Failure

Ileostomy - Stoma Clinical Trial

— REINFUSE  

Official title:

Pivotal Study 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04577456
• Other study ID #: TICL-001 G190281
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Databean
• Contact: John Davidson
• Phone: +6498879309
• Email: john[@]insidescompany.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age = 21 years
• Able to provide written informed consent
• Dependent on parenteral nutrition (PN)
• DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall
• Minimum of 2 weeks post DES/ECF creation
• Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)

Exclusion Criteria:

• Insufficient distal access channel (distal limb) for device insertion
• Bowel obstruction proximal to the DES/ECF
• Small bowel obstruction, anastomotic leak, or perforation distal to the DES/ECF (diagnostic procedure such as gastrografin test, fistulograms, or similar must be performed, if there is a distal anastomosis with integrity not previously evaluated, to ensure that the subject is eligible)
• Scheduled for DES/ECF reversal within 4 weeks of enrolment date
• Current infection with Clostridium difficile colitis
• Current infection small intestinal bacterial overgrowth (SIBO)
• Signs or symptoms of systemic infection
• Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis
• Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson's disease, hypothyroidism
• Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if only discovered at time of closure)
• Liver cirrhosis
• Hereditary coagulopathy, e.g., von Willebrand disease
• Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2)
• Active implantable medical devices such as neuromodulation and cardiac systems
• Metal stents implanted within 20cm of expected use of the controller
• Women who are pregnant or breastfeeding
• Subjects participating in an interventional clinical study within 30 days prior to randomization

Related Conditions & MeSH terms

• Enterocutaneous Fistula
• Fistula
• Ileostomy - Stoma
• Intestinal Failure
• Intestinal Fistula

Intervention

Device:
• The Insides System
Novel pump designed to return effluent from the ostomy bag to the distal gut

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	St James Hospital	Leeds
United Kingdom	St Marks Hospital	London
United Kingdom	Nottingham University Hospital	Nottingham
United Kingdom	University Hospital Southampton	Southampton
United States	Massachusetts General Medical Center	Boston	Massachusetts
United States	University Illinois	Chicago	Illinois
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Shands Hospital	Gainesville	Florida
United States	University Nebraska	Lincoln	Nebraska
United States	University Miami Hospital and Clinics	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Databean	The Insides Company

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Proportion of subjects who discontinue the use of parenteral nutrition at 30 days	Between group comparison of the proportion of subjects who discontinue the use of parenteral nutrition	30 days post randomization
Secondary	Efficacy - Between group comparison of the time to discontinuation of parenteral nutrition	Between group comparison of the time to discontinuation of parenteral nutrition measured in days	30 days
Secondary	Efficacy - Between group comparison of the time to fistula closure	Between group comparison of the time to surgery for fistula closure measured in days	90 days
Secondary	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	90 days
Secondary	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.	30 and 90 days
Secondary	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).	30 and 90 days
Secondary	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	30 and 90 days
Secondary	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	up to 30 days
Secondary	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	90 days
Secondary	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	90 days
Secondary	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.	90 days
Secondary	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 following: EuroQol 5D scale - a five question survey and health thermometer where 0= the worst health you can imagine and 100= the best health you can imagine.; 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: Always; Sometimes; Rarely; Not at all	30 and 90 days
Secondary	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: Always; Sometimes; Rarely; Not at all	30 and 90 days
Secondary	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	30 and 90 days