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Prosthetic Device
Chyme Reinfusion Device for Intestinal Failure (REINFUSE Trial)
N/A
Recruiting
Led By Mohammed - Syed Jafri, MD
Research Sponsored by Databean
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall
Age ≥ 21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 and 90 days
Awards & highlights
REINFUSE Trial Summary
This trialaims to introduce a new device to help treat fluid and nutrient loss from enterocutaneous fistulas, returning output back into the intestine.
Who is the study for?
This trial is for adults over 21 with Type 2 Intestinal Failure who rely on parenteral nutrition due to enterocutaneous fistulas. They must have visible intestinal openings and be able to insert a feeding tube into the distal limb. Excluded are those with upcoming surgery, certain infections, systemic infection signs, pregnant or breastfeeding women, recent clinical study participants, specific bowel issues like obstruction or motility disorders, severe kidney disease, liver cirrhosis, coagulopathy, metal stents near the device area or active implantable devices.Check my eligibility
What is being tested?
The trial tests 'The Insides System,' a prosthetic designed to return nutrients and fluids from an intestinal fistula back into the intestine. It aims to reduce dependency on parenteral nutrition by reinfusing chyme (digestive fluid) through afferent and efferent limbs of the intestine in patients with this condition.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of insertion, risk of infection due to reintroduction of intestinal contents back into the body's system which could lead to complications if not monitored properly.
REINFUSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have visible surgical connections on my abdomen.
Select...
I am 21 years old or older.
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I rely on nutrition given through my veins.
REINFUSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 and 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 and 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy - Proportion of subjects who discontinue the use of parenteral nutrition at 30 days
Secondary outcome measures
Device performance - The overall incidence of device related adverse effects
Efficacy - Between group comparison of the time to discontinuation of parenteral nutrition
Efficacy - Between group comparison of the time to fistula closure
+10 moreREINFUSE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Reinfusion of chyme using the Insides System for subjects with Type II intestinal failure dependent on PN
Group II: ControlActive Control1 Intervention
Standard of care therapies in accordance with ASPEN and ESPEN treatment guidelines
Find a Location
Who is running the clinical trial?
The Insides CompanyIndustry Sponsor
DatabeanLead Sponsor
4 Previous Clinical Trials
292 Total Patients Enrolled
The Insides Company Ltd. ManufacturerUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A feeding tube can be placed in my digestive system opening.You have active implantable medical devices, like devices that help with nerve stimulation or heart function.I am currently infected with C. difficile.I have liver cirrhosis.I have an infection caused by too many bacteria in my small intestine.I have a genetic blood clotting disorder, like von Willebrand disease.I was aware of or discovered cancer spread to my abdomen during surgery.I am not pregnant or breastfeeding.I have visible surgical connections on my abdomen.It has been at least 2 weeks since my dialysis access surgery.I have a condition like MS, Parkinson's, or hypothyroidism affecting my colon's movement.I have a blockage in my intestines above the stomach entrance.I am showing signs of an infection that affects my whole body.I have a condition that affects how food moves through my stomach or intestines.My kidney function is severely low.You have metal stents placed within 20cm of where the controller will be used.I've had tests confirming no blockage or leaks in my intestines after a specific diagnostic procedure.I am scheduled for a surgery to reverse my digestive system's operation within the next 4 weeks.I am 21 years old or older.I rely on nutrition given through my veins.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Active
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to individuals in this research trial?
"Affirmative, records on clinicaltrials.gov show that this research endeavour is currently open to volunteers. The trial was initially published in October 15th 2022 and its last edit took place on January 9th 2023; the study needs 40 individuals from 3 different sites for participation."
Answered by AI
How many individuals are eligible for inclusion in this experiment?
"Affirmative. According to the information on clinicaltrials.gov, this medical research is recruiting volunteers as of now. The trial was made available on October 15th 2022 and its latest update occurred January 9th 2023 with 40 prospective participants being sought from 3 distinct sites."
Answered by AI
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