NCT04032951

Brief Summary

To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

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, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

January 19, 2015

Last Update Submit

July 24, 2019

Conditions

Abdominal Neoplasms

Keywords

EUS-guided biopsy

Outcome Measures

Primary Outcomes (1)

  • - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.

    diagnostic accuracy

    intraoperative

Secondary Outcomes (1)

  • rate of complications

    perioperative

Study Arms (1)

Adominal neoplasms patients

EXPERIMENTAL

Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.

Other: Fine Needle Tissue Acquisition

Interventions

Fine Needle Tissue AcquisitionOTHER

diagnostic

Also known as: FNTA
Adominal neoplasms patients

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 and less than 80.
  • Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
  • Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
  • Informed consent is obtained

You may not qualify if:

  • Previous biopsy of the lesion with diagnosis of malignancy
  • Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
  • They are unable to understand and/or read the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ISMETT

Palermo, Italy

Location

Universita cattolica del sacro cuore

Rome, Italy

Location

MeSH Terms

Conditions

Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • GUIDO COSTAMAGNA, PROF

    Catholic University of the Sacred Heart

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 19, 2015

First Posted

July 25, 2019

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

IT(2)