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RECRUITING
NCT05535361
NA

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

Sponsor: Eclipse Regenesis, Inc.

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

3 Months - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-15

Completion Date

2028-06-30

Last Updated

2025-10-08

Healthy Volunteers

No

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.

Locations (6)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University School of Medicine

Stanford, California, United States

Children's National Hospital

Washington D.C., District of Columbia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States