Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

NCT03211780 | Terminated FDA Device

• 1 other identifier: 17-002253
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Determining malignant esophageal tissue from normal tissue

  Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system.

  1 week

Study Arms (1)

Ultrasound

EXPERIMENTAL

Device: General Electric LOGIQ E9 ultrasound system

Interventions

General Electric LOGIQ E9 ultrasound system DEVICE

Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
• Subject is able to understand the study procedures and provide informed consent.

You may not qualify if:

• Subject is pregnant or breast feeding.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Dennis Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Matthew Urban, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: September 20, 2017
• Primary Completion: April 24, 2019
• Study Completion: April 24, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)