NCT05521685

Brief Summary

The purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for Gastric Varices performed by Indiana University EUS physicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

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

April 19, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

August 2, 2022

Last Update Submit

January 10, 2024

Conditions

Gastric Varices Bleeding

Outcome Measures

Primary Outcomes (1)

  • Impact of EUS guided treatment of Gastric varices post procedure complications and adverse events

    Retrospective data review to Determine post procedure complications and adverse events at 24h, between 2 and 7 days and between 8 and 30 days after the procedure. Additionally, tracking rebleeding after first and second EUS. Moreover, looking at eradication of GV rate on second endoscopy (considered eradicated if absent or if residual varices have no or minimal flow on doppler)eradication, and need for re-intervention following cyanoacrylate tissue adhesive treatment for Gastric Varices performed by IU EUS physicians.

    Complications reviewed at time of retrospective study. EUS-guided sclerotherapy done between November 2012 and December 2021

Interventions

Endoscopic Ultrasound (EUS) administration of cyanoacrylate tissue adhesive to control bleeding gastric varicesPROCEDURE

Subjects will have undergone treatment and been enrolled into the existing registry.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects were treated for Gastric Varices with bleeding using cyanoacrylate tissue adhesive and administered by endoscopic ultrasound.

You may qualify if:

  • Any subject enrolled into the existing database (IU IRB#1209009522; NCT02037659).

You may not qualify if:

  • Not enrolled into the database.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • John M. DeWitt, MD

    Professor of Medicine and Director of Endoscopic Ultrasound

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Director of Endoscopic Ultrasound

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 30, 2022

Study Start

April 19, 2022

Primary Completion

May 22, 2023

Study Completion

May 22, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)