NCT04693754

Brief Summary

The purpose of having this database is to collect data related to endoscopic ultrasound RFA procedures performed by Indiana University EUS physicians for the treatment of tumors or adenopathy. This database is a repository database only, all information will be obtained in the electronic medical record. No additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. The patient will have already signed an informed consent for the endoscopic ultrasound. Subjects will be entered into the database for up to 10 years after the most recent procedure.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress56%
Jul 2020Dec 2030

Study Start

First participant enrolled

July 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

10.5 years

First QC Date

July 16, 2020

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Incidence of any procedural complications that occur during the procedure on date of procedure.

    This data will be used for to determine the clinical impact and safety of these procedures.

    Day of procedure

  • Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)

    1 week phone follow up

    1 week following procedure

  • Rate of patient report of symptoms related to procedure (Acute pancreatitis, abdominal pain, infection/abscess, venous thrombosis, & fever)

    2 week phone follow up

    2 weeks following procedure

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Above 14 years of age and referred for treatment of benign or malignant tumor or adenopathy

You may qualify if:

  • Subjects 14 years of age and older Referral for the treatment of a benign or malignant tumor or adenopathy

You may not qualify if:

  • Subjects less than 14 years of age Unable to comprehend the study consent due to language or disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202-5121, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invstigator

Study Record Dates

First Submitted

July 16, 2020

First Posted

January 5, 2021

Study Start

July 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations