NCT04281875 · REGISTRY CONDITION SEARCH

Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2024-10-17

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

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outcome · POSTED

Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)

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outcome · POSTED

Postoperative Hypoparathyroidism/Hypocalcemia (Transient)

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outcome · POSTED

Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)

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outcome · POSTED

Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).

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outcome · POSTED

Number of Auto-transplanted Parathyroid Glands

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outcome · POSTED

Number of Nights Spent in the Hospital After Total Thyroidectomy

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outcome · POSTED

Number of Inadvertently Resected Parathyroid Glands

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: (i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid). (ii) All patients undergoing completion thyroidectomy. Exclusion Criteria: (i) Patients with concurrent parathyroid disease. (ii) Patients with incidental enlarged parathyroid discovered during TTx. (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
healthy Volunteers: false
maximum Age: 99 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
intervention Names
Device: NIRAF Detection Technology
label
NIRAF Detection Technology +
type
EXPERIMENTAL
description
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
label
NIRAF Detection Technology -
type
NO_INTERVENTION

interventions

arm Group Labels
NIRAF Detection Technology +
description
Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
name
NIRAF Detection Technology
other Names
PTeye Device
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group. Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology). The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (nm) laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).

masking Info

masking: SINGLE
masking Description: Only participants will be masked to the intervention.
who Masked: PARTICIPANT

primary Purpose

PREVENTION

Enrollment

count: 160
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
measure
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
time Frame
Immediate. During total thyroidectomy procedure.

secondary Outcomes

description
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
measure
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)
time Frame
6 months after total thyroidectomy
description
Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).
measure
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)
time Frame
5 days to 6 months after total thyroidectomy.
description
Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery
measure
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)
time Frame
Within 24 hours after total thyroidectomy.
description
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
measure
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).
time Frame
Immediate. During total thyroidectomy procedure.
description
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
measure
Number of Auto-transplanted Parathyroid Glands
time Frame
Immediate. During total thyroidectomy procedure.
description
Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, \>1 night
measure
Number of Nights Spent in the Hospital After Total Thyroidectomy
time Frame
0 - 4 nights after total thyroidectomy
description
Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
measure
Number of Inadvertently Resected Parathyroid Glands
time Frame
Intraoperatively or on histology (within 24 hours post operation)

Full study description

brief Summary: This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
detailed Description: Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (\< 6 months) in 5 - 35% of cases or permanent hypocalcemia (\> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach (3 - 5) as utilized in 'PTeye', which is medical device that was recently FDA-cleared (6). However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.

Source references

references

citation
Antakia R, Edafe O, Uttley L, Balasubramanian SP. Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis. Thyroid. 2015 Jan;25(1):95-106. doi: 10.1089/thy.2014.0101.
pmid
25203484
type
BACKGROUND
citation
Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
pmid
24402815
type
BACKGROUND
citation
McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9.
pmid
26454675
type
BACKGROUND
citation
Thomas G, McWade MA, Paras C, Mannoh EA, Sanders ME, White LM, Broome JT, Phay JE, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Developing a Clinical Prototype to Guide Surgeons for Intraoperative Label-Free Identification of Parathyroid Glands in Real Time. Thyroid. 2018 Nov;28(11):1517-1531. doi: 10.1089/thy.2017.0716. Epub 2018 Sep 11.
pmid
30084742
type
BACKGROUND
citation
Thomas G, McWade MA, Nguyen JQ, Sanders ME, Broome JT, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Innovative surgical guidance for label-free real-time parathyroid identification. Surgery. 2019 Jan;165(1):114-123. doi: 10.1016/j.surg.2018.04.079. Epub 2018 Nov 12.
pmid
30442424
type
BACKGROUND
citation
Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768. No abstract available.
pmid
30512085
type
BACKGROUND
citation
Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.
pmid
40668552
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice