EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)
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|ClinicalTrials.gov Identifier: NCT01735786|
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment|
|Endoscopic Hemostasis Colonic Polyps||Device: EndoClot|
|Study Type :||Observational|
|Actual Enrollment :||164 participants|
|Official Title:||EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
Subjects in this group will received Endoclot treatment immediately after EMR.
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Subjects in this group will not received any hemostasis treatment after EMR.
- Rebleeding rate after EMR procedure [ Time Frame: up to 1 week ]Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.
- Mucosal healing after EMR [ Time Frame: up to 1 month ]Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
- gastrointestinal tract obstruction [ Time Frame: up to 1 month ]Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735786
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shanxi, China, 710032|
|Principal Investigator:||Zhiguo Liu, M.D.||Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032|