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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037659
Other study ID # Dermabond
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date March 2022

Study information

Verified date March 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.


Description:

Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date March 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Anyone receiving treatment with DermaBond for treatment gastric varices. Exclusion Criteria: No evidence of gastric varices. -

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
DermaBond treatment of Gastric Varices
Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.

Locations

Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required. 36 months
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