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
Eclipse Regenesis, Inc.
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
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…
Eligibility
- Age range
- 0–65 years
- Sex
- All
- Healthy volunteers
- No
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 vis…
Interventions
- DeviceDistraction 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.
Locations (6)
- Lucile Packard Children's Hospital StanfordPalo Alto, California
- University of California San FranciscoSan Francisco, California
- Stanford University School of MedicineStanford, California
- Children's National HospitalWashington D.C., District of Columbia
- Boston Children's HospitalBoston, Massachusetts
- Cincinnati Children's HospitalCincinnati, Ohio