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

NCT03032198 | Terminated Results FDA Device

• 1 other identifier: Thyroid-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Thyroid Feasibility Study

Conditions

Feasibility Study for Thyroid Indication

Outcome Measures

Primary Outcomes (1)

• Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.

  The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.

  12-24 months

Study Arms (1)

Imagio OA/US Scan

EXPERIMENTAL

Imagio opto-acoustic gray-scale ultrasound scan

Device: Imagio OA/US

Interventions

Imagio OA/US DEVICE

Diagnostic opto-acoustic gray-scale ultrasound

Also known as: opto-acoustic gray-scale ultrasound

Imagio OA/US Scan

Eligibility Criteria

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

You may qualify if:

• Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
• Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
• years of age or older at the time of consent;
• Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
• 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.

You may not qualify if:

• Are prisoners;
• 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),
• Previous or on-going radioactive iodine treatment.
• Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
• Is pregnant;
• Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
• Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
• Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
• Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
• 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,
• Patient has previously participated in this study.

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead

Study Sites (2)

Invision Sally Jobe

Greenwood Village, Colorado, 80111, United States

Location

UT Health Science Center

San Antonio, Texas, 78229, United States

Location

Limitations and Caveats

The study was discontinued due to change in corporate strategy. This Early R\&D Development Study was terminated early due to change in corporate strategy. The reader portion of the study was not initiated per the protocol, therefore was no data generated for the primary and secondary endpoints to analyze.

Results Point of Contact

• Title: Shaan Schaeffer
• Organization: Seno Medical, Inc.

sschaeffer@senomedical.com

6106983259

Study Officials

• Tom Stavros, MD

  Seno Medical, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 26, 2017
• Study Start: December 4, 2017
• Primary Completion: June 17, 2018
• Study Completion: April 19, 2019
• Last Updated: August 2, 2022
• Results First Posted: July 13, 2022

Record last verified: 2022-07

Locations

US (2)