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
| NCT ID | NCT05535361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eclipse Regenesis, Inc. |
| Condition | Short Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-09-15 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 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 visits and complete all study related procedures (as determined by the investigator). Exclusion Criteria: * Ultra-short bowel syndrome defined as less than 3 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05535361 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 65 Years, studying Short Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05535361 currently recruiting?
Yes, NCT05535361 is actively recruiting participants. Contact the research team at andre@eclipseregenesis.com for enrollment information.
Where is the NCT05535361 trial being conducted?
This trial is being conducted at Palo Alto, United States, San Francisco, United States, Washington D.C., United States, Boston, United States and 1 additional location.
Who is sponsoring the NCT05535361 clinical trial?
NCT05535361 is sponsored by Eclipse Regenesis, Inc.. The trial plans to enroll 40 participants.