NCT02037659

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

9.3 years

First QC Date

January 14, 2014

Last Update Submit

March 27, 2022

Conditions

Gastric Varices

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Gastric Varices treatment

DermaBond (glue) treatment of Gastric Varices.

Procedure: DermaBond treatment of Gastric Varices

Interventions

DermaBond treatment of Gastric VaricesPROCEDURE

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

Also known as: DermaBond: (cyanoacrylate tissue adhesive).
Gastric Varices treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with DermaBond for gastric varices.

You may qualify if:

  • Anyone receiving treatment with DermaBond for treatment gastric varices.

You may not qualify if:

  • No evidence of gastric varices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • John M. DeWitt, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Endoscopic Ulatrsound

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

December 1, 2012

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)