Clinical trial NCT05535361: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: short bowel syndrome
intestinal failure
Necrotizing enterocolitis
short gut
intestinal volvulus
intestinal atresia
Lead sponsor: Eclipse Regenesis, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's Hospital Medical Center, Cincinnati
name: Stanford University
name: University of California, San Francisco
name: Boston Children's Hospital
First posted: 2022-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The first phase of the study shall consisted of 5 subjects (aged 18 to 50 years) with an FDA review after 3 subjects with defunctional and functional limbs. Phase 1 initial adult subjects were enrolled and assessed in order to demonstrate an acceptable safety profile. FDA approval was received to advance to subsequent phases of the study.

This next phase (Phase 2) consists of 10 subjects (aged 12 months to 65 years) at 6 centers in the United States.

Device placement will be administered during a previously planned procedure that is otherwise needed by the study subject. Study assessments for the objectives will be collected by radiographic examination to determine length of intestinal lengthening and assessment of safety and clinical improvement until the device is removed or passes out of the intestine naturally. The surgeon shall also review ultrasounds and complete blood counts daily for 7 days post-operatively and weekly post-7 days until device passage or removal to assess for intussusception or infection. Follow up will continue 30 days after the device is removed or naturally passed by the subject. 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 the entire length of study, depending on subject health

Eligibility criteria: 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 10 cm.
* Male or female patients aged 12 months to 65 years inclusive
* Subject has scheduled open abdominal procedure for different indication than study device (i.e., ostomy take-down, stoma-take-down, open liver biopsy, and procedures to correct the following: bowel obstruction, strictures, adhesions).
* 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:

* Previously performed intestinal resection and/or bowel lengthening procedure \< 6 months from screening visit.
* Ultra-short bowel syndrome defined as less than 10 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.

Primary outcomes:
measure: Device and procedure related adverse events
timeFrame: 4 to 6 months
Secondary outcomes:
measure: Assess the lengthening of the small intestine
timeFrame: 4 to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.