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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03032198
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Seno Medical Instruments Inc.

Study Description
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Brief Summary:
Thyroid Feasibility Study

Condition or disease Intervention/treatment Phase
Feasibility Study for Thyroid Indication Device: Imagio OA/US Not Applicable

Detailed Description:
This is an early R&D Study

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Imagio OA/US Scan
Imagio opto-acoustic gray-scale ultrasound scan
 Device: Imagio OA/US
Diagnostic opto-acoustic gray-scale ultrasound
Other Name: opto-acoustic gray-scale ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. Initial assessment of Imagio's ability to distinguish between benign and malignant thyroid nodules. [ Time Frame: 12-24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032198


Locations
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United States, Colorado
Invision Sally Jobe
Greenwood Village, Colorado, United States, 80111
United States, Texas
UT Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Seno Medical Instruments Inc.
More Information
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Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT03032198     History of Changes
Other Study ID Numbers: Thyroid-01
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms