GERD Clinical Trial
Official title:
Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study
This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.
The word "investigational" means the PEGJ feeding tube used in this study is not approved by
the U. S. Food and Drug Administration (FDA) and is still being tested in research studies.
Currently commercially available PEGJ tubes are long tubes which are placed into the part of
the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The
tip of these PEGJ tubes usually have some built-in extra weight (several grams), which
theoretically should prevent slippage of the tube back into the stomach. However, these
tubes usually cannot be placed very far into the duodenum and the build-in weight is usually
not sufficient to keep the tube in place.
The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks)
migrates back into the stomach and at that point the tube needs to be replaced. The
investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on
its tip. The tip of this tube is directed endoscopically through the part of the stomach
that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and
the endoscope is removed. The water filled balloon then is carried by the movement of the
intestinal muscles through the duodenum into the middle section of the small intestine
(jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube
and presence of the water-filled balloon on its tip will prevent migration of the tube back
into the stomach and therefore eliminates the need for tube replacement.
The only difference between the currently approved PEGJ feeding tube and the investigational
one being used in this study is the addition of the balloon to the tip of the J port. People
who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and
who are not pregnant may join the study.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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