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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 3 cm.

• Male or female patients aged 3 mo to 65 years inclusive

• 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).

Locations
United States
California
Lucile Packard Children's Hospital Stanford
RECRUITING
Palo Alto
University of California San Francisco
RECRUITING
San Francisco
Stanford University School of Medicine
RECRUITING
Stanford
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Contact Information
Primary
Andre Bessette
andre@eclipseregenesis.com
(617)249-0955
Backup
Eric Bannon
ebannon@alvamed.com
(781)710-8243
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 40
Treatments
Experimental: Eclipse XL1 Coil Treatment Group
All subjects will be assigned to the XL1 Coil treatment group.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, Boston Children's Hospital, Lucile Packard Children's Hospital at Stanford, Children's Hospital Medical Center, Cincinnati, University of California, San Francisco, Children's National Health System, Washington DC
Leads: Eclipse Regenesis, Inc.

This content was sourced from clinicaltrials.gov