Dermabond Treatment for Gastric Variceal Bleeding

NCT ID: NCT02037659

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Varices

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric Varices treatment

DermaBond (glue) treatment of Gastric Varices.

DermaBond treatment of Gastric Varices

Intervention Type PROCEDURE

Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DermaBond treatment of Gastric Varices

Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DermaBond: (cyanoacrylate tissue adhesive).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria

No evidence of gastric varices.

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indiana University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John DeWitt

Director, Endoscopic Ulatrsound

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John M. DeWitt, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Dermabond

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.