"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"

NCT ID: NCT03032198

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2019-04-19

Brief Summary

Thyroid Feasibility Study

Detailed Description

This is an early R&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules

Conditions

Feasibility Study for Thyroid Indication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Imagio OA/US Scan

Imagio opto-acoustic gray-scale ultrasound scan

Group Type: EXPERIMENTAL

Imagio OA/US

Intervention Type: DEVICE

Diagnostic opto-acoustic gray-scale ultrasound

Interventions

Imagio OA/US

Diagnostic opto-acoustic gray-scale ultrasound

Intervention Type: DEVICE

Other Intervention Names

opto-acoustic gray-scale ultrasound

Eligibility Criteria

Inclusion Criteria

1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;

2. Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;

3. 18 years of age or older at the time of consent;

4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,

5. Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.

Exclusion Criteria

1. Are prisoners;

2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule),

3. Previous or on-going radioactive iodine treatment.

4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter;

5. Is pregnant;

6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;

7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;

8. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;

9. Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;

10. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and,

11. Patient has previously participated in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seno Medical Instruments Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom Stavros, MD

Role: PRINCIPAL_INVESTIGATOR

Seno Medical, Inc.

Locations

Invision Sally Jobe

Greenwood Village, Colorado, United States

UT Health Science Center

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Thyroid-01

Identifier Type: -

Identifier Source: org_study_id