Endoscopic Full Thickness Biopsy, Gastric Wall.
|ClinicalTrials.gov Identifier: NCT01650714|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Other: Full thickness gastric biopsy Procedure: Full thickness gastric biopsy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Full thickness gastric biopsy
Full thickness gastric biopsy
Other: Full thickness gastric biopsy
Procedure: Full thickness gastric biopsy
- Number of patients with successful endoscopic full thickness gastric resection [ Time Frame: one week after surgery ]Success of the endoscopic resection will be defined by efficacy and safety: 1) Efficacy is defined as obtaining a full thickness resection and 2) Safety is defined as the absence of serious adverse events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650714
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator:||Elizabeth Rajan, MD||Mayo Clinic|