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Chyme Reinfusion for Type 2 Intestinal Failure

NCT04577456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Intestinal Failure
  • Enterocutaneous Fistula
  • Ileostomy - Stoma
  • High Output Stoma

Interventions

DEVICE

The Insides System

Novel pump designed to return effluent from the ostomy bag to the distal gut

Sponsors & Collaborators

  • Databean

    collaborator INDUSTRY

  • Green Lane Coordinating Centre Limited

    collaborator UNKNOWN

  • BioValeo

    collaborator INDUSTRY

  • The Insides Company

    lead INDUSTRY

Principal Investigators

  • Dermot Burke, MD · St. James Hospital, Leeds, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2025-11-17
Completion
2025-11-18
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577456 on ClinicalTrials.gov