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

Study Overview
=================
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

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

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eclipse XL1 Coil Treatment Group<br>All subjects will be assigned to the XL1 Coil treatment group. | Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome<br>* 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.<br>|

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 |