MedTrace Logo

Whipple Procedure: Standard of Care vs. Thunderbeat

NCT02204124 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-09-19

Study results available
· View outcomes & findings →

Summary

The Whipple procedure is the standard method for therapy for cancerous tumors, inflammation, and stenosis (narrowing) near the head of the pancreas. This is a prospective study to assess whether or not use of the Thunderbeat™ device may decrease blood loss and postoperative morbidity (the presence of illness or disease). The findings will then be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.

Conditions

  • Pancreatic Neoplasms
  • Bile Duct Carcinoma

Interventions

DEVICE

Thunderbeat

Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.

DEVICE

Standard of care scissors, ligatures, clips, and sutures

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • William Hawkins, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-08-23
Completion
2017-08-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02204124 on ClinicalTrials.gov