Gastroparesis Clinical Trial
Official title:
Endoscopic Full Thickness Biopsy of the Gastric Wall in Patients With Refractory Idiopathic Gastroparesis: Pilot Study to Detect Neuromuscular and Immune Pathologic Changes
The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.
Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap
(SEMF) technique to acquire full thickness gastric tissues successfully and safely in
preclinical studies.
The proposed study will assess the efficacy and safety of the innovative endoscopic
technique for the acquisition of full thickness gastric muscle wall biopsies. Having access
to full thickness biopsies will allow an increased understanding of the pathophysiology of
gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis,
pseudoobstruction and other motility disorders. This information is essential to development
of more targeted and effective therapy than currently available. Despite the high prevalence
of functional gastrointestinal disorders and its significant impact on social and health
care costs, the underlying cause is not well understood and there is no effective specific
treatment to successfully alleviate patient symptoms.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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