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

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

Study Overview

• Status: Recruiting
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Detailed Description

This clinical investigation is a study to evaluate safety and probable benefit of the Eclipse XL1 System in pediatric and adult subjects with short bowel syndrome. This study is a single arm study and will enroll subjects ages 3 months to 65 years old at up to 10 study sites in the United States. This study will be open label; treatment allocation will be known by the subjects, the Principal Investigator and his medical staff. Recruitment is expected to occur over the course of 24-36 months.

Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for a portion or the entire length of study, depending on subject health.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andre Bessette; Phone Number: (617)249-0955; Email: andre@eclipseregenesis.com
• Study Contact Backup: Name: Eric Bannon; Phone Number: (781)710-8243; Email: ebannon@alvamed.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Lucile Packard Children's Hospital Stanford
      • Contact: Shweta Namjoshi, MD; Phone Number: (650) 721-2250; Email: namjoshi@stanford.edu
      • Principal Investigator: Shweta Namjoshi, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Principal Investigator: Matthew Lin, MD
      • Contact: Matthew Lin, MD; Phone Number: (415) 476-0972; Email: Matthew.Lin@ucsf.edu
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University School of Medicine
      • Principal Investigator: Joseph Forrester, MD
      • Contact: Anisha Abreo; Phone Number: 650 723 4000; Email: aabreo@stanford.edu
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Contact: Clarivet Torres, MD; Phone Number: 202-476-2115; Email: ctorres@childrensnational.org
      • Principal Investigator: Clarivet Torres, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Meghan Fitzgerald; Phone Number: (617) 355-4729; Email: Meghan.Fitzgerald@childrens.harvard.edu
      • Principal Investigator: Mark Puder, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3026
      • Recruiting
      • Cincinnati Children's Hospital
      • Principal Investigator: Paul Wales, MD
      • Contact: Beth Cobb; Phone Number: 405-850-1349; Email: Beth.Cobb@cchmc.org
      • Principal Investigator: Michael Helmrath, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device and procedure related adverse events	Incident rate of moderate or severe procedure and/or device related adverse events	4 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the lengthening of the small intestine	Assess the lengthening of the small intestine via the Eclipse XL1 Coil.	4 to 6 months
Improvement in overall nutritional status	Improvement in overall nutritional status at 6 months post final implantation compared to pre-procedure as evidenced by change in parenteral, enteral, oral intake; stool frequency and quality; weight.	6 to 12 months

Collaborators and Investigators

• Sponsor: Eclipse Regenesis, Inc.
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Boston Children's Hospital; University of California, San Francisco; Stanford University; Children's Hospital Medical Center, Cincinnati; Lucile Packard Children's Hospital at Stanford; Children's National Health System, Washington DC

Publications and helpful links

General Publications

• Park J, Puapong DP, Wu BM, Atkinson JB, Dunn JC. Enterogenesis by mechanical lengthening: morphology and function of the lengthened small intestine. J Pediatr Surg. 2004 Dec;39(12):1823-7. doi: 10.1016/j.jpedsurg.2004.08.022.
• Chang PC, Mendoza J, Park J, Lam MM, Wu B, Atkinson JB, Dunn JC. Sustainability of mechanically lengthened bowel in rats. J Pediatr Surg. 2006 Dec;41(12):2019-22. doi: 10.1016/j.jpedsurg.2006.08.014.
• Mendoza J, Chang CY, Blalock CL, Atkinson JB, Wu BM, Dunn JC. Contractile function of the mechanically lengthened intestine. J Surg Res. 2006 Nov;136(1):8-12. doi: 10.1016/j.jss.2006.01.027. Epub 2006 Sep 18.
• Shekherdimian S, Scott A, Chan A, Dunn JC. Intestinal lengthening in rats after massive small intestinal resection. Surgery. 2009 Aug;146(2):291-5. doi: 10.1016/j.surg.2009.03.034. Epub 2009 Jun 21.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: short bowel syndrome; Necrotizing enterocolitis; intestinal failure; short gut; intestinal atresia; intestinal volvulus
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Malabsorption Syndromes; Congenital Abnormalities; Intestinal Obstruction; Digestive System Abnormalities; Torsion Abnormality; Enterocolitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Intestinal Failure; Short Bowel Syndrome; Enterocolitis, Necrotizing; Intestinal Volvulus; Intestinal Atresia
• Other Study ID Numbers: CLIN-0001; R44DK127658 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No