NCT04577456

Chyme Reinfusion for Type 2 Intestinal Failure

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: The Insides Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	The Insides System	Novel pump designed to return effluent from the ostomy bag to the distal gut

Timeline

• Start date: 2022-10-15
• Primary completion: 2025-11-17
• Completion: 2025-11-18
• First posted: 2020-10-08
• Last updated: 2025-12-08

Locations

11 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study