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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.
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.
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.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Shands Hospital
Gainesville, Florida, United States
University Miami Hospital and Clinics
Miami, Florida, United States
University Illinois
Chicago, Illinois, United States
University Nebraska
Lincoln, Nebraska, United States
Royal Devon and Exeter Hospital
Exeter, United Kingdom
St James's Hospital
Leeds, United Kingdom
St Mark's Hospital
London, United Kingdom
Salford Royal Hospital
Manchester, United Kingdom
Royal Victoria Hospital
Newcastle upon Tyne, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Start Date
October 15, 2022
Primary Completion Date
November 17, 2025
Completion Date
November 18, 2025
Last Updated
December 8, 2025
44
ACTUAL participants
The Insides System
DEVICE
Lead Sponsor
The Insides Company
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05902104