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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Eclipse Regenesis, Inc.
Study ID
NCT05535361
Status
Recruiting
Apply to this trial

Conditions

  • Short Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
3 Months - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome — DEVICE
    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.

Study Details

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 Dates

Start date
Sep 15, 2025
Status verified
Oct 2025
Primary completion
Mar 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Eclipse XL1 Coil Treatment Group
    All subjects will be assigned to the XL1 Coil treatment group.

Primary Outcome Measure

Device and procedure related adverse events [ Time Frame: 4 to 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94303
Shweta Namjoshi, MD
[email protected]
(650) 721-2250
Shweta Namjoshi, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Matthew Lin, MD
[email protected]
(415) 476-0972
Matthew Lin, MD (PRINCIPAL_INVESTIGATOR)
Stanford University School of MedicineStanfordCalifornia94304
Anisha Abreo
[email protected]
650 723 4000
Joseph Forrester, MD (PRINCIPAL_INVESTIGATOR)
Children's National HospitalWashington D.C.District of Columbia20010
Clarivet Torres, MD
[email protected]
202-476-2115
Clarivet Torres, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
Meghan Fitzgerald
[email protected]
(617) 355-4729
Mark Puder, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's HospitalCincinnatiOhio45229-3026
Beth Cobb
[email protected]
405-850-1349
Michael Helmrath, MD (PRINCIPAL_INVESTIGATOR)
Paul Wales, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By research site
Lucile Packard Children's Hospital Stanford· Palo Alto, CAUniversity of California San Francisco· San Francisco, CAStanford University School of Medicine· Stanford, CAChildren's National Hospital· Washington D.C., DCBoston Children's Hospital· Boston, MACincinnati Children's Hospital· Cincinnati, OH

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