Recruiting

Eclipse XL1

Sponsor:

Eclipse Regenesis, Inc.

Code:

NCT05535361

Conditions

Short Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Interventions

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Study Details

Brief 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

Conditions

Short Bowel Syndrome

Study ID

NCT05535361

Start date

Sep 15, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Ultra-short bowel syndrome defined as less than 3 cm of bowel length.
  • Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
  • Evidence of active or prior Crohn's disease.
  • Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
  • Coagulopathy, as defined by INR > 1.4 or platelets < 100.
  • Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
  • Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eclipse XL1 Coil Treatment Group

All subjects will be assigned to the XL1 Coil treatment group.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Andre Bessette

(617)249-0955andre@eclipseregenesis.com

Eric Bannon

(781)710-8243ebannon@alvamed.com

Locations

Lucile Packard Children's Hospital Stanford

Recruiting

Palo Alto, California, United States, 94303

Contacts

Shweta Namjoshi, MD

(650) 721-2250namjoshi@stanford.edu

Principal Investigator:

Shweta Namjoshi, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Matthew Lin, MD

(415) 476-0972Matthew.Lin@ucsf.edu

Principal Investigator:

Matthew Lin, MD

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Clarivet Torres, MD

202-476-2115ctorres@childrensnational.org

Principal Investigator:

Clarivet Torres, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Meghan Fitzgerald

(617) 355-4729Meghan.Fitzgerald@childrens.harvard.edu

Principal Investigator:

Mark Puder, MD

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229-3026

Contacts

Beth Cobb

405-850-1349Beth.Cobb@cchmc.org

Principal Investigator:

Michael Helmrath, MD

More Information

Sponsor

Eclipse Regenesis, Inc.

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • short bowel syndrome
  • intestinal failure
  • Necrotizing enterocolitis
  • short gut
  • intestinal volvulus
  • intestinal atresia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eclipse Regenesis, Inc. on 2026-08-12.