Comparing PTeye-assisted Versus Conventional Total Thyroidectomy

NCT07416149 | Recruiting DMC FDA Device

• 1 other identifier: UW-25-412
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce post-operative hypoparathyroidism (PH). The study will enroll consecutive patients undergoing total thyroidectomy in a teritary endocrine surgery unit in Hong Kong, randomizing them into receiving conventional surgery versus PTeye™-assisted surgery. Subjects will be assigned to the two groups before surgery. Subjects will be under medical care as in usual practice.

Conditions

Hypocalcemia; Parathyroid; Hypoparathyroidism Post-surgical; Total Thyroidectomy

Keywords

Thyroidectomy; calcium; hypocalcemia; post operation; hypoparathyroidism; PTeye™ parathyroid detection system

Outcome Measures

Primary Outcomes (1)

• Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)

  Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)

  6 months

Secondary Outcomes (6)

• Rate of inadvertent parathyroidectomy (in %)

  within 4 weeks from operation

• Rate of parathyroid auto-transplantation (in %)

  within operation

• Day 0 PTH

  Post-operative Day 0

• Day 1 Post-operative serum parathyroid hormone levels (pmol/L)

  Post-operative Day 1

• 3-month Post-operative serum parathyroid hormone levels (pmol/L)

  Post-operative 3 months

Study Arms (2)

Total thyroidectomy with the PTeye™ parathyroid detection system

ACTIVE COMPARATOR

PTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery.

Device: PTeye™ parathyroid detection system

Conventional total thyroidectomy

NO INTERVENTION

Total thyroidectomy without PTeye™

Interventions

PTeye™ parathyroid detection system DEVICE

The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.

Total thyroidectomy with the PTeye™ parathyroid detection system

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥18 years of age
• Undergoing total thyroidectomy, or completion total thyroidectomy
• Pre-operative serum adjusted calcium levels within normal ranges

You may not qualify if:

• Patients on pre-operative calcium or vitamin D supplements
• Patients with pre-operative vitamin D deficiency, defined as serum vitamin D\<30nmol/L
• Patients with untreated primary or secondary hyperparathyroidism
• Patient with known non-surgical hypoparathyroidism diseases
• Patients with estimated glomerular filtration rate \<30ml/1.73m2/min, on dialysis, or having a history of kidney transplant

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (20)

• Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15:

  BACKGROUND

• Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14:

  BACKGROUND

• Lui DTW, Fung MMH, Lee CH, Fong CHY, Woo YC, Lang BHH. A territory-wide assessment of the incidence of persistent hypoparathyroidism after elective thyroid surgery and its impact on new fracture risk over time. Surgery. 2021 Nov;170(5):1369-1375. doi: 10.1016/j.surg.2021.05.004. Epub 2021 Jun 8.

  PMID: 34116859 BACKGROUND

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  PMID: 31804401 BACKGROUND

• Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6.

  PMID: 29122325 BACKGROUND

• Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31.

  PMID: 30710614 BACKGROUND

• Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chereau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.

  PMID: 31693081 BACKGROUND

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  PMID: 31305127 BACKGROUND

• 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 BACKGROUND

• Paras C, Keller M, White L, Phay J, Mahadevan-Jansen A. Near-infrared autofluorescence for the detection of parathyroid glands. J Biomed Opt. 2011 Jun;16(6):067012. doi: 10.1117/1.3583571.

  PMID: 21721833 BACKGROUND

• Manatakis DK, Balalis D, Soulou VN, Korkolis DP, Plataniotis G, Gontikakis E. Incidental Parathyroidectomy during Total Thyroidectomy: Risk Factors and Consequences. Int J Endocrinol. 2016;2016:7825305. doi: 10.1155/2016/7825305. Epub 2016 Aug 18.

  PMID: 27635137 BACKGROUND

• Luk Y, Fung MMH, Lui DTW, Liu X, Li L, Wong CKH, Lang BHH. Long-term kidney outcomes in patients with permanent hypoparathyroidism after total thyroidectomy for benign disease: A population-based study. Surgery. 2024 Sep;176(3):700-707. doi: 10.1016/j.surg.2024.05.005. Epub 2024 Jun 15.

  PMID: 38880699 BACKGROUND

• Ivanovic-Zuvic D, Chelebifski S, Uribe B, Quintana C, Dominguez JM, Olmos R, Florenzano P. Impaired Quality of Life in Patients with Post-Surgical Hypoparathyroidism. J Bone Metab. 2024 May;31(2):140-149. doi: 10.11005/jbm.2024.31.2.140. Epub 2024 May 31.

  PMID: 38886971 BACKGROUND

• Hillary SL, Chooi JE, Wadsley J, Newell-Price JD, Brown NJ, Balasubramanian SP. Quality of Life in Post-Surgical Hypoparathyroidism (PoSH) in Thyroid and Parathyroid Surgery. World J Surg. 2022 Dec;46(12):3025-3033. doi: 10.1007/s00268-022-06730-7. Epub 2022 Oct 2.

  PMID: 36184675 BACKGROUND

• Buttner M, Singer S, Taylor K. Quality of life in patients with hypoparathyroidism receiving standard treatment: an updated systematic review. Endocrine. 2024 Jul;85(1):80-90. doi: 10.1007/s12020-024-03807-2. Epub 2024 Apr 5.

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• Pasieka JL, Wentworth K, Yeo CT, Cremers S, Dempster D, Fukumoto S, Goswami R, Houillier P, Levine MA, Pasternak JD, Perrier ND, Sitges-Serra A, Shoback DM. Etiology and Pathophysiology of Hypoparathyroidism: A Narrative Review. J Bone Miner Res. 2022 Dec;37(12):2586-2601. doi: 10.1002/jbmr.4714. Epub 2022 Nov 23.

  PMID: 36153665 BACKGROUND

• Jorgensen CU, Homoe P, Dahl M, Hitz MF. Postoperative Chronic Hypoparathyroidism and Quality of Life After Total Thyroidectomy. JBMR Plus. 2021 Mar 16;5(4):e10479. doi: 10.1002/jbm4.10479. eCollection 2021 Apr.

  PMID: 33869995 BACKGROUND

• Frey S, Figueres L, Pattou F, Le Bras M, Caillard C, Mathonnet M, Hamy A, Brunaud L, Lifante JC, Tresallet C, Sebag F, Menegaux F, Blanchard C, Leroy M, Mirallie E; Qol-Hypopara Study Group. Impact of Permanent Post-thyroidectomy Hypoparathyroidism on Self-evaluation of Quality of Life and Voice: Results From the National QoL-Hypopara Study. Ann Surg. 2021 Nov 1;274(5):851-858. doi: 10.1097/SLA.0000000000005129.

  PMID: 34353986 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia; Hypoparathyroidism

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Endocrine System Diseases

Central Study Contacts

Man Him, Matrix Fung, MBBS

CONTACT

+852 2255 4232; mmhfung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The study design and sample size calculation was validated by an experienced biostatistician. Preliminary data showed rate of significant post-operative hypoparathyroidism (SPH) was 17.7% lower with PTeye use. A sample size of 89 per group will achieve 80% power to detect between-group difference of 17.7%. The calculations are based on a one-sided Z-Test with the significance level of 0.05. Allowing for a 15% loss to followup, 105 patients per arm (210 in total) will be recruited for the trial. Eligible patients will be first stratified to benign and malignant diseases, then randomly assigned at a 1:1 ratio to receive either PTeye-assisted or conventional surgery according to a pre-generated block randomization list. Allocation sequence will be concealed in sequentially numbered, opaque, sealed, and stapled envelopes. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments, just before surgery.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 17, 2026
• Study Start: September 16, 2025
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

HK (1)