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New Hand-Held imager aims to prevent accidental parathyroid damage in thyroid surgery

NCT ID NCT06939946

Diagnosis Sponsor: OPTOSURGICAL, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early study tested a hand-held imaging device to help surgeons identify parathyroid glands during thyroid surgery. The parathyroid glands are small and hard to see, and if accidentally removed or damaged, can cause low calcium levels and other complications. The device uses auto-fluorescence and sometimes a green dye to make the glands visible. The study enrolled 20 adults having thyroid surgery, but was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Parathyroid auto-fluorescence imaging device (Hand-Held Imager) and Indocyanine green (ICG) dye
What this could lead to
If successful, this device could help surgeons better identify parathyroid glands during thyroid surgery, potentially reducing accidental removal or damage and lowering complication rates.
What could go wrong
This was a very early, small feasibility study that was terminated, so results are limited. The device may not improve outcomes significantly, and ICG dye carries a small risk of allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Sep 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation. * Plan for surgical resection of pathological PTGs. * Subject age 18 - 70 yo. * Subject agreement to participate Exclusion Criteria: * Not eligible for endocrine surgeries * Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment) * Subject age younger than 18 yo or older than 70 yo * Subject refusal to participate * Subject cognitively impaired and/or unable to provide assent. * Allergy to indocyanine green and iodine.

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Conditions

The condition(s) this trial relates to.

parathyroid gland disorder thyroid gland disorder thyroid tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parathyroid gland Thyroid disease Thyroid surgery

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.