NCT05535361

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

September 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
3 years until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

September 1, 2022

Last Update Submit

October 3, 2025

Conditions

Short Bowel Syndrome

Keywords

short bowel syndromeintestinal failureNecrotizing enterocolitisshort gutintestinal volvulusintestinal atresia

Outcome Measures

Primary Outcomes (1)

  • Device and procedure related adverse events

    Incident rate of moderate or severe procedure and/or device related adverse events

    4 to 6 months

Secondary Outcomes (2)

  • Assess the lengthening of the small intestine

    4 to 6 months

  • Improvement in overall nutritional status

    6 to 12 months

Study Arms (1)

Eclipse XL1 Coil Treatment Group

EXPERIMENTAL

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

Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Interventions

Distraction Enterogenesis in Adult Patients with Short Bowel SyndromeDEVICE

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.

Eclipse XL1 Coil Treatment Group

Eligibility Criteria

Age3 Months - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94303, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University School of Medicine

Stanford, California, 94304, United States

RECRUITING

Children's National Hospital

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

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 15616941BACKGROUND

  • 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.

    PMID: 17161196BACKGROUND

  • 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.

    PMID: 16979663BACKGROUND

  • 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.

    PMID: 19628087BACKGROUND

MeSH Terms

Conditions

Short Bowel SyndromeIntestinal FailureEnterocolitis, NecrotizingIntestinal VolvulusIntestinal Atresia

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsEnterocolitisGastroenteritisIntestinal ObstructionTorsion AbnormalityPathological Conditions, AnatomicalDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Andre Bessette

CONTACT

(617)249-0955andre@eclipseregenesis.com

Eric Bannon

CONTACT

(781)710-8243ebannon@alvamed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 10, 2022

Study Start

September 15, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(6)