Ileostomy - Stoma Clinical Trial
— REINFUSEOfficial 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.
Verified date | August 2023 |
Source | Databean |
Contact | John Davidson |
Phone | +6498879309 |
john[@]insidescompany.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Databean | The Insides Company |
United States, United Kingdom,
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 |
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