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Tests treatment safety and results for Short Bowel Syndrome
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
ClinicalTrials.gov ID: NCT05535361
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 65
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; San Francisco, California, United States; Stanford, California, United States; Washington D.C., District of Columbia, United States; Boston, Massachusetts, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.