NCT02042859

Brief Summary

The purpose of this study is to determine whether the use of an FDA approved endoscopic bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic ducts.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1 pancreatic-cancer

Status
unknown

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

February 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

January 15, 2014

Last Update Submit

January 20, 2014

Conditions

Pancreatic Cancer

Keywords

EndoHPB

Outcome Measures

Primary Outcomes (1)

  • Improvement in size(patency of bile duct) measured by cholangiography or cholangioscopy, immediately post ablation

    Baseline through visit 7

Interventions

Endoscopic Bipolar RadioFrequency Probe used to remove tumors in bile duct to manage Pancreatic CancerDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Either gender greater than or equal to 18 years of age.
  • Pancreatic Cancer or Cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced disease.
  • Biliary Obstruction
  • Subjects capable of giving informed consent
  • Life expectancy of at least 3 months

You may not qualify if:

  • Cardiac Pacemaker
  • Patient unstable for endoscopy
  • Inability to give informed consent
  • Uncorrected coagulopathy
  • Pregnancy
  • Karnofsky score less than 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Virendra Joshi, MD

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 23, 2014

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 23, 2014

Record last verified: 2014-01