Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT05535361
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2022-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Eclipse Regenesis, Inc.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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 that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. 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 a portion or the entire length of study, depending on subject health.
Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. 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 a portion or the entire length of study, depending on subject health.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44DK127658 | NIH | None | https://reporter.nih.gov/quic… | View |