Actively Recruiting
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
Led by Eclipse Regenesis, Inc. · Updated on 2025-10-08
40
Participants Needed
6
Research Sites
145 weeks
Total Duration
On this page
Sponsors
E
Eclipse Regenesis, Inc.
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with short bowel syndrome having 50% or less of expected bowel length based on age and/or height
- Minimum of 3 cm residual bowel length
- Male or female, aged 3 months to 65 years inclusive
- Ability to read, understand, and provide informed consent (or parent/legal guardian able to consent)
- Willingness and ability to attend all clinic visits and complete study procedures as required
You will not qualify if you...
- Less than 3 cm of bowel length (ultra-short bowel syndrome)
- Diagnosed with inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
- Evidence of active or prior Crohn's disease
- Primary intestinal failure without loss or resection of intestinal tissue
- Coagulopathy defined as INR > 1.4 or platelets < 100
- Known immunocompromised status including recent organ transplant, chemotherapy, radiotherapy, clinically significant leukopenia, or HIV positive
- Investigator determines the participant is unsuitable for trial participation for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94303
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Stanford University School of Medicine
Stanford, California, United States, 94304
Actively Recruiting
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229-3026
Actively Recruiting
Research Team
A
Andre Bessette
CONTACT
E
Eric Bannon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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