NCT01798654

Brief Summary

The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-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

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

February 22, 2013

Last Update Submit

February 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients who suffered bleeding complication

    One week

Study Arms (1)

Antithrombotic agents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In hospital

You may qualify if:

  • Undergo EUS-FNA
  • take antithrombotic agents

You may not qualify if:

  • Cystic lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Graduate School of Medicine

Sapporo, 0808648, Japan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. and Ph.D.

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 26, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations