Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 10:11 PM
Study NCT ID:
NCT04577456
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2020-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chyme Reinfusion for Type 2 Intestinal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Global multi center prospective randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-09-30', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '30 days post randomization', 'description': 'Between group comparison of the proportion of subjects who achieve a 50% reduction in the use of parenteral nutrition'}], 'secondaryOutcomes': [{'measure': 'Efficacy - Between group comparison of the time to reduction in the use of PN', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of the time to reduction of parenteral nutrition measured in days'}, {'measure': 'Efficacy - Between group comparison of the time to discontinuation in the use of PN', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of the time to discontinuation in the use of PN'}, {'measure': 'Efficacy - Between group comparison of the time to reduction in the use of other parentral support fluids', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of the time to reduction in the use of other parenteral support fluids'}, {'measure': 'Safety - Between group comparison of the incidence of serious adverse events', 'timeFrame': '30 and 60 days', 'description': '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'}, {'measure': 'Efficacy - Between group comparison of the time to ostomy closure', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of the time to surgery for ostomy closure measured in days'}, {'measure': 'Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of the use of proton pump inhibitors, anti motility agents, histamine receptor antagonists, a2 receptor antagonists, and somatostatins.'}, {'measure': 'Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)', 'timeFrame': '30 and 60 days', 'description': '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).'}, {'measure': 'Safety - Between group comparison of peristomal skin complications', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of peristomal skin complications measured by the discoloration, erosion, tissue overgrowth (DET) score as mild, moderate or severe'}, {'measure': 'Healthcare Utilization - Between group comparison of length of stay for index hospitalization', 'timeFrame': 'up to 30 days', 'description': 'Between group comparison of length of stay for index hospitalization measured from the day of randomization to discharge'}, {'measure': 'Healthcare Utilization - Between group comparison of all cause hospitalizations', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of all cause hospitalizations measured by the total number of discreet hospitalizations \\>24 hours in duration'}, {'measure': 'Healthcare Utilization - Between group comparison of hospitalizations due to dehydration', 'timeFrame': '30 and 60 days', 'description': 'Between group comparison of hospital admissions \\>24 hours duration where the primary reason for admission is dehydration'}, {'measure': 'Device performance - The overall incidence of device related adverse effects', 'timeFrame': '30 and 60 days', 'description': '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.'}, {'measure': 'Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D', 'timeFrame': '30 and 60 days', 'description': '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.'}, {'measure': 'Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire', 'timeFrame': '30 and 60 days', 'description': '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:\n\n1. Always\n2. Sometimes\n3. Rarely\n4. Not at all'}, {'measure': 'Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory', 'timeFrame': '30 and 60 days', 'description': '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\n\n1-10\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Chyme reinfusion', 'Intestinal failure', 'TPN or PN', 'Parenteral nutrition', 'Enterocutaneous fistula', 'Effluent', 'Ileostomy - stoma', 'Refeeding'], 'conditions': ['Intestinal Failure', 'Enterocutaneous Fistula', 'Ileostomy - Stoma', 'High Output Stoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThere 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 21 years\n* Able to provide written informed consent\n* Dependent on parenteral nutrition (PN)\n* DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall\n* Minimum of 2 weeks post DES/ECF creation\n* Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)\n\nExclusion Criteria:\n\n* Insufficient distal access channel (distal limb) for device insertion\n* Bowel obstruction proximal to the DES/ECF\n* 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)\n* Scheduled for DES/ECF reversal within 4 weeks of enrolment date\n* Current infection with Clostridium difficile colitis\n* Current infection small intestinal bacterial overgrowth (SIBO)\n* Signs or symptoms of systemic infection\n* Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis\n* Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson's disease, hypothyroidism\n* Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if only discovered at time of closure)\n* Liver cirrhosis\n* Hereditary coagulopathy, e.g., von Willebrand disease\n* Severe chronic renal insufficiency prior to DES/ECF formation (eGFR\\<30mL/min/1.73m2)\n* Active implantable medical devices such as neuromodulation and cardiac systems\n* Metal stents implanted within 20cm of expected use of the controller\n* Women who are pregnant or breastfeeding\n* Subjects participating in an interventional clinical study within 30 days prior to randomization"}, 'identificationModule': {'nctId': 'NCT04577456', 'acronym': 'REINFUSE', 'briefTitle': 'Chyme Reinfusion for Type 2 Intestinal Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Insides Company'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'TICL-001 G190281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN', 'interventionNames': ['Device: The Insides System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines'}], 'interventions': [{'name': 'The Insides System', 'type': 'DEVICE', 'description': 'Novel pump designed to return effluent from the ostomy bag to the distal gut', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Miami Hospital and Clinics', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '68198', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University Nebraska', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW107NS', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Mark's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M6 8HD', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Dermot Burke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. James Hospital, Leeds, UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Insides Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Databean', 'class': 'INDUSTRY'}, {'name': 'Green Lane Coordinating Centre Limited', 'class': 'UNKNOWN'}, {'name': 'BioValeo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}