Test a new esophagus implant to rebuild a short esophagus segment
Part of Digestive system clinical trials.
This Phase 1 study tests the safety and feasibility of a new esophagus implant for people who need only a short (about 6 cm or less) section of their esophagus rebuilt after serious injury or scarring. If it does not work, you must be willing to have a planned “rescue” surgery later.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older.
- You have an esophagus problem that needs reconstruction, such as stubborn narrowing, an esophagus tear, or a long-lasting abnormal connection (fistula).
- You have already tried at least 3 different treatments and they did not work (for certain problem types).
- Your planned esophagus surgery involves only a short section (≤6 cm for Cohort 1; <7 cm for Cohort 2) and is in the chest (not below the diaphragm, and at least 4 cm below the voice box).
- You can have a thoracotomy (a chest surgery approach) but are not able to do laparoscopic or robotic “gastric pull-up” surgery due to medical reasons.
- You must be willing and able to follow the study schedule and agree to written consent; you must also agree to possible delayed rescue surgery if the implant fails to work.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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