The Insides™ Company, a leading
provider of automated chyme reinfusion solutions, today
announced the first patient has been enrolled in the
REINFUSE clinical study. REINFUSE is a 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.
The REINFUSE study is a world first in
assessing the effect of chyme reinfusion therapy versus
standard of care in a randomised controlled study. The first
patient to be enrolled in the study is an important
milestone towards US market approval for The Insides
System.
The Insides System received Breakthrough
Device designation from the US Food and Drug Administration
(FDA) in 2019, and the REINFUSE trial received an
investigation device exemption (IDE) for the study in 2021.
The trial will be conducted at sites in the United States
and the United Kingdom and will enrol 40 patients to
investigate the clinical outcomes of chyme reinfusion
therapy using The Insides System versus the standard of care
for patients with type 2 intestinal failure.
Associate
Professor Dermot Burke (Leeds Teaching Hospital, UK) and Dr
Syed-Mohammed Jafri (Henry Ford Health, USA) lead the
clinical trial. Associate Professor Burke said “Although
type 2 intestinal failure is an uncommon problem, the
consequences for an individual can be very severe and life
changing. The Insides System has the potential to
dramatically improve the quality of life for patients with
this condition. This trial should enable the medical
research team to confirm the value of The Insides System and
so provide patients with hope of a better
life”.
About Type 2 Intestinal
Failure
Intestinal failure is when a large
part of the intestine is missing or does not work properly.
This means the gut does not digest and absorb food the way
it should. Type 2 intestinal failure is prolonged intestinal
failure which requires life-sustaining parenteral nutrition
(feeding though a vein) for longer than 20 days.
Type
2 intestinal failure can be caused following an acute
traumatic event such as a traffic accident, following
surgical procedures associated with anastomotic leaks,
vascular or viscous injury during other surgery, creation of
laparostomy (open abdominal wound), and acute unpredictable
events such as enterocutaneous fistulae, intestinal
volvulus, and mesenteric infarction.
About
Chyme Reinfusion Therapy
Chyme is the medical
term used to describe partially digested contents of the
small intestine. Chyme reinfusion therapy involves returning
chyme collected in a patient’s ostomy appliance from the
proximal (i.e., upstream) limb of the fistula or stoma, back
into the distal (i.e., downstream) limb.
Chyme
reinfusion is recommended by the European Society of
Clinical Nutrition and Metabolism (ESPEN) and American
Society for Parenteral and Enteral Nutrition (ASPEN) for the
nutrition in patients with acute intestinal
failure.
About The Insides
System
The Insides System is a medical device
that enables chyme to be refeed into the intestine for
enterostomy and enterocutaneous fistula patients. The
Insides System is commercially available in the United
Kingdom, Europe, and New Zealand.
About The
Insides™ Company
The
Insides™ Company is a leading designer and manufacturer of
purpose-built chyme reinfusion solutions for patients with
intestinal failure. The company’s devices demonstrate
significant improvements in clinical and economic outcomes
for patients requiring intestinal
rehabilitation.
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