Evaluating the Eclipse XL1 System for treating Short Bowel Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and potential benefits of the Eclipse XL1 System for distraction enterogenesis in patients with Short Bowel Syndrome. It involves a phased approach, starting with adult subjects and expanding to include pediatric patients. Participants will undergo device placement during a necessary surgical procedure, with follow-up assessments to monitor intestinal lengthening and safety outcomes. The study aims to gather data on the effectiveness of this innovative device in improving intestinal function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lucile Packard Children's Hospital Stanford
  Palo Alto, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Cincinnati Children's Hospital
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Andre Bessette
• Email: andre@eclipseregenesis.com
• Phone: (617)249-0955

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Resting energy tests in people with normal digestion vs. intestinal failure

  This study tests resting energy expenditure in adults with and without intestinal failure to help tailor nutrition needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07714499

• FT1 for adults with short bowel syndrome: a safe, quick-study test

  This trial tests FT1 vs placebo in adults with short bowel syndrome to see if FT1 is safe and helps with their condition.

  Recruiting Phase 2 Chongqing Peg-Bio Biopharm Co., Ltd. · Nanjing, Jiangsu · NCT07704047

• Glepaglutide for adults with short bowel syndrome and intestinal failure

  This trial tests whether glepaglutide 10 mg given twice weekly can reduce the need for parenteral support in adults with short bowel syndrome and intestinal failure.

  Recruiting at 32 sites Phase 3 Zealand Pharma · Chicago, Illinois and 32 other locations · NCT07197944

• Crofelemer for adults with short bowel syndrome and intestinal failure without a colon

  This trial will test whether taking crofelemer three times a day helps adults with short bowel syndrome and intestinal failure who lack a colon and need parenteral support.

  Recruiting at 8 sites Phase 2 Napo Therapeutics, S.p.A. · Aachen and 7 other locations · NCT06904872

• Creating a quick quality-of-life questionnaire for people with short bowel syndrome

  This project will try a shorter, easier quality-of-life questionnaire for adults with short bowel syndrome and compare it with the existing SBS QoL tool.

  Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT06771505

• Assessing a new treatment for Short Bowel Syndrome

  This study is testing a new treatment for adults with Short Bowel Syndrome to see if it can help improve their condition compared to a placebo.

  Recruiting at 15 sites Phase 2 Hanmi Pharmaceutical Company Limited · Boston, Massachusetts and 14 other locations · NCT04775706

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.