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Chyme Reinfusion for Type 2 Intestinal Failure (REINFUSE)

Primary Purpose

Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The Insides System
Sponsored by
Databean
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Failure focused on measuring Chyme reinfusion, Intestinal failure, TPN or PN, Parenteral nutrition, Enterocutaneous fistula, Effluent, Ileostomy - stoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shands Hospital
  • University Miami Hospital and Clinics
  • University IllinoisRecruiting
  • Massachusetts General Medical Center
  • Henry Ford Medical CenterRecruiting
  • University NebraskaRecruiting
  • Addenbrooke's Hospital
  • St James HospitalRecruiting
  • St Marks HospitalRecruiting
  • Nottingham University HospitalRecruiting
  • University Hospital SouthamptonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active

Control

Arm Description

Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN

Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Efficacy - Between group comparison of the time to fistula closure
Between group comparison of the time to surgery for fistula closure measured in 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
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.
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).
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
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
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
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
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.
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
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
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

Full Information

First Posted
September 16, 2020
Last Updated
August 22, 2023
Sponsor
Databean
Collaborators
The Insides Company
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1. Study Identification

Unique Protocol Identification Number
NCT04577456
Brief Title
Chyme Reinfusion for Type 2 Intestinal Failure
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Databean
Collaborators
The Insides Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma
Keywords
Chyme reinfusion, Intestinal failure, TPN or PN, Parenteral nutrition, Enterocutaneous fistula, Effluent, Ileostomy - stoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Global multi center prospective randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines
Intervention Type
Device
Intervention Name(s)
The Insides System
Intervention Description
Novel pump designed to return effluent from the ostomy bag to the distal gut
Primary Outcome Measure Information:
Title
Efficacy - Proportion of subjects who discontinue the use of parenteral nutrition at 30 days
Description
Between group comparison of the proportion of subjects who discontinue the use of parenteral nutrition
Time Frame
30 days post randomization
Secondary Outcome Measure Information:
Title
Efficacy - Between group comparison of the time to discontinuation of parenteral nutrition
Description
Between group comparison of the time to discontinuation of parenteral nutrition measured in days
Time Frame
30 days
Title
Efficacy - Between group comparison of the time to fistula closure
Description
Between group comparison of the time to surgery for fistula closure measured in days
Time Frame
90 days
Title
Safety - Between group comparison of the incidence of serious adverse events
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
Time Frame
90 days
Title
Safety - Between group comparison of medication use to control fluid loss due to high output enterostomies
Description
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 90 days
Title
Safety - Between group comparison of nutritional failure measured by the nutritional risk index (NRI)
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).
Time Frame
30 and 90 days
Title
Safety - Between group comparison of peristomal skin complications
Description
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 90 days
Title
Healthcare Utilization - Between group comparison of length of stay for index hospitalization
Description
Between group comparison of length of stay for index hospitalization measured from the day of randomization to discharge
Time Frame
up to 30 days
Title
Healthcare Utilization - Between group comparison of all cause hospitalizations
Description
Between group comparison of all cause hospitalizations measured by the total number of discreet hospitalizations >24 hours in duration
Time Frame
90 days
Title
Healthcare Utilization - Between group comparison of hospitalizations due to dehydration
Description
Between group comparison of hospital admissions >24 hours duration where the primary reason for admission is dehydration
Time Frame
90 days
Title
Device performance - The overall incidence of device related adverse effects
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.
Time Frame
90 days
Title
Quality of Life - Between group comparison of quality of life indices as measured by the EuroQol 5D
Description
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
Time Frame
30 and 90 days
Title
Quality of Life - Between group comparison of quality of life indices as measured by the Stoma QoL Questionnaire
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: Always Sometimes Rarely Not at all
Time Frame
30 and 90 days
Title
Quality of Life - Between group comparison of quality of life indices as measured by the Beck Depression Inventory
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 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 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Davidson
Phone
+6498879309
Email
john@insidescompany.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haytham Helmi, MD
Phone
+18446643001
Ext
1
Email
haythamh@databean.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed - Syed Jafri, MD
Organizational Affiliation
Henry Ford Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Rosenthal, MD
Facility Name
University Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liran Barda, MD
Email
exp554@miami.edu
Facility Name
University Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Carroll, MD
Email
sudhamai@uic.edu
Facility Name
Massachusetts General Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02145
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Velmahos, MD
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Syed-Jafri, MD
Email
JPERUSK1@hfhs.org
Facility Name
University Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mercer, MD
Email
jill.povondra@unmc.edu
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Fernhead, MD
Email
magda.gerigk1@nhs.net
Facility Name
St James Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermot Burke, MD
Email
kerry.bode@nhs.net
Facility Name
St Marks Hospital
City
London
ZIP/Postal Code
NW107NS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolynn Vaizey, MD
Email
michela.cicchetti@nhs.net
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Spence
Email
rachel.spence2@nuh.nhs.uk
Facility Name
University Hospital Southampton
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Layfield, MD
Email
priya.mathew3@uhs.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Chyme Reinfusion for Type 2 Intestinal Failure

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