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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

March 1, 2028

Study Completion Date

June 30, 2028

Conditions
Short Bowel Syndrome
Interventions
DEVICE

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.

Trial Locations (6)

20010

RECRUITING

Children's National Hospital, Washington D.C.

94143

RECRUITING

University of California San Francisco, San Francisco

94303

RECRUITING

Lucile Packard Children's Hospital Stanford, Palo Alto

94304

RECRUITING

Stanford University School of Medicine, Stanford

02115

RECRUITING

Boston Children's Hospital, Boston

45229-3026

RECRUITING

Cincinnati Children's Hospital, Cincinnati

Sponsors
All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Stanford University

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

Boston Children's Hospital

OTHER

collaborator

Lucile Packard Children's Hospital at Stanford

UNKNOWN

collaborator

Children's National Health System, Washington DC

UNKNOWN

lead

Eclipse Regenesis, Inc.

OTHER

NCT05535361 - 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 | Biotech Hunter | Biotech Hunter