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Not recruiting

Prosthetic System

Sponsor:

The Insides Company

Code:

NCT04577456

Conditions

Intestinal Failure

Enterocutaneous Fistula

Ileostomy - Stoma

High Output Stoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

The Insides System

Study Details

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.

Conditions

Intestinal Failure

Enterocutaneous Fistula

Ileostomy - Stoma

High Output Stoma

Study ID

NCT04577456

Start date

Oct 15, 2022

Status verified date

May, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

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

no intervention: Control

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

Interventions

The Insides System

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

Primary outcome 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. [ Time Frame: 30 days post randomization ]

Central Contacts and Locations

Central contacts

John Davidson, PhD

+6498879309john@insidescompany.com

Caroline Alsweiler

+1 (202) 439-9308insides@glcc.co.nz

Locations

Shands Hospital

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Martin Rosenthal, MD

352-273-5670martin.rosenthal@surgery.ufl.edu

University Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Liran Barda, MD

exp554@miami.edu

University Nebraska

Recruiting

Lincoln, Nebraska, United States, 68198

Contacts

David Mercer, MD

jill.povondra@unmc.edu

More Information

Sponsor

The Insides Company

Last update posted

May 7, 2025

Last verified

May, 2025

Keywords

  • Chyme reinfusion
  • Intestinal failure
  • TPN or PN
  • Parenteral nutrition
  • Enterocutaneous fistula
  • Effluent
  • Ileostomy - stoma
  • Refeeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by The Insides Company on 2025-05-07.