A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome

Description

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome

Conditions

Short Bowel Syndrome

Study Overview

Study Details

Study overview

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome

Condition
Short Bowel Syndrome
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University School of Medicine, Stanford, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection.
  • * Minimum residual bowel length of 10 cm.
  • * Male or female patients aged 12 months to 65 years inclusive
  • * Subject has scheduled open abdominal procedure for different indication than study device (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and procedures to correct the following: bowel obstruction, strictures, adhesions).
  • * The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent.
  • * The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).
  • * Previously performed intestinal resection and/or bowel lengthening procedure \< 6 months from screening visit.
  • * Ultra-short bowel syndrome defined as less than 10 cm of bowel length.
  • * Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
  • * Evidence of active or prior Crohn's disease.
  • * Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
  • * Coagulopathy, as defined by INR \> 1.4 or platelets \< 100.
  • * Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
  • * Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.

Ages Eligible for Study

12 Months to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eclipse Regenesis, Inc.,

Study Record Dates

2026-06