Back to results

A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS

Primary Purpose

Short Bowel Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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 18 to 50 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.

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eclipse XL1 Coil Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

Device and procedure related adverse events

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

Secondary Outcome Measures

Assess the lengthening of the small intestine

Assess the lengthening of the small intestine via the Eclipse XL1 Coil.

Full Information

NCT ID

NCT05535361

First Posted

September 1, 2022

Last Updated

October 13, 2023

Sponsor

Eclipse Regenesis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05535361

Brief Title

A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS

Official Title

A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult Patients With Short Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2023 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eclipse Regenesis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System in Adult Patients with Short Bowel Syndrome shall enroll up to 5 Subjects at up to 2 study sites in the United States.

Detailed Description

The first phase of the study shall consists 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 will be enrolled and assessed in order to demonstrate an acceptable safety profile. FDA approval will be received before advancing to subsequent phases of the study. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eclipse XL1 Coil Treatment Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Intervention Description

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 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 Information:

Title

Device and procedure related adverse events

Description

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

Time Frame

4 to 6 months

Secondary Outcome Measure Information:

Title

Assess the lengthening of the small intestine

Description

Assess the lengthening of the small intestine via the Eclipse XL1 Coil.

Time Frame

4 to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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 18 to 50 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andre Bessette

Phone

(617)249-0955

andre@eclipseregenesis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Bannon

Phone

(781)710-8243

ebannon@alvamed.com

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anisha Abreo

Phone

650-723-4000

aabreo@stanford.edu

First Name & Middle Initial & Last Name & Degree

Joseph Forrester, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15616941

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.

Results Reference

background

PubMed Identifier

17161196

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.

Results Reference

background

PubMed Identifier

16979663

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.

Results Reference

background

PubMed Identifier

19628087

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.

Results Reference

background

Learn more about this trial

A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS

We'll reach out to this number within 24 hrs