HypocalcemiaNCT07416149
Comparing PTeye-assisted Versus Conventional Total Thyroidectomy
A study testing PTeye™ parathyroid detection system in people with Hypocalcemia and Parathyroid, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia, Parathyroid, Hypoparathyroidism Post-surgical
- What is being tested?
- PTeye™ parathyroid detection system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years of age
- Undergoing total thyroidectomy, or completion total thyroidectomy
- Pre-operative serum adjusted calcium levels within normal ranges
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Man Him, Matrix Fung, MBBS, mmhfung@hku.hk
About this study
Official title: Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
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.
Read the detailed description
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
- Being tested
- PTeye™ parathyroid detection system
- Keywords
- Thyroidectomy, calcium, hypocalcemia, post operation, hypoparathyroidism, PTeye™ parathyroid detection system
- Medical subject headings
- Hypocalcemia, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTeye™ parathyroid detection systemDevice
The PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PTeye™ parathyroid detection system |
| Conventional total thyroidectomy | No intervention | Total thyroidectomy without PTeye™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Measured: 6 months
Secondary outcomes (6)
Rate of inadvertent parathyroidectomy (in %)
Rate of inadvertent parathyroidectomy (in %)
Measured: within 4 weeks from operation
Rate of parathyroid auto-transplantation (in %)
Rate of parathyroid auto-transplantation (in %)
Measured: within operation
Day 0 PTH
Day 0 Post-operative serum parathyroid hormone levels (pmol/L)
Measured: Post-operative Day 0
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Measured: Post-operative Day 1
3-month Post-operative serum parathyroid hormone levels (pmol/L)
3-month Post-operative serum parathyroid hormone levels (pmol/L)
Measured: Post-operative 3 months
6-month Post-operative serum parathyroid hormone levels (pmol/L)
6-month Post-operative serum parathyroid hormone levels
Measured: Post-operative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start16 Sep 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Him Matrix Fung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416149
- Sponsor's protocol ID
- UW-25-412
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15:
Hospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14:
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.
PubMed 34116859Edafe 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.
PubMed 24402815Payne RB, Little AJ, Williams RB, Milner JR. Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J. 1973 Dec 15;4(5893):643-6. doi: 10.1136/bmj.4.5893.643.
PubMed 4758544Solorzano CC, Thomas G, Baregamian N, Mahadevan-Jansen A. Detecting the Near Infrared Autofluorescence of the Human Parathyroid: Hype or Opportunity? Ann Surg. 2020 Dec;272(6):973-985. doi: 10.1097/SLA.0000000000003700.
PubMed 31804401Benmiloud 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.
PubMed 29122325Dip 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.
PubMed 30710614Benmiloud 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.
PubMed 31693081DiMarco A, Chotalia R, Bloxham R, McIntyre C, Tolley N, Palazzo FF. Does fluoroscopy prevent inadvertent parathyroidectomy in thyroid surgery? Ann R Coll Surg Engl. 2019 Sep;101(7):508-513. doi: 10.1308/rcsann.2019.0065. Epub 2019 Jul 15.
PubMed 31305127McWade 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.
PubMed 26454675Paras 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.
PubMed 21721833Manatakis 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.
PubMed 27635137Luk 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.
PubMed 38880699Ivanovic-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.
PubMed 38886971
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Post-operative Hypoparathyroidism With Probe-based Near Infrared Autofluorescence (NIRAF)- Assisted Total Thyroidectomy Versus Conventional Total Thyroidectomy, a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT07416149
- Acronym / sponsor ID
- UW-25-412
- Keywords
- Thyroidectomy, calcium, hypocalcemia, post operation, hypoparathyroidism, PTeye™ parathyroid detection system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-operative hypoparathyroidism (PH) is a debilitating complication following total thyroidectomy. It arises from inadvertent removal or devascularization of the parathyroid glands. From a previous study in Hong Kong and other population-wide series, permanent PH rates could be as high as 11%, and transient PH rates being 30-48%, posing substantial burden on healthcare systems.
Near-infrared autofluorescence (NIRAF) technology has emerged to assist the identification and preservation of parathyroid glands during surgery. This study investigates the probe-based NIRAF device, PTeye™, which emits laser and receives NIR real-time, thereby detecting parathyroid glands by a simple touch of a probe.
A standardized protocol is devised to use PTeye™ for parathyroid identification at the early stage of surgery, in order to avoid devascularization or inadvertent removal of the parathyroids.
This is a prospective, single-blinded, randomized controlled trial to evaluate whether PTeye™ can reduce PH. The study will enroll consecutive patients undergoing total thyroidectomy in a tertiary endocrine surgery unit in Hong Kong. Patients will be randomized to receive conventional surgery or PTeye™-assisted surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Total thyroidectomy with the PTeye™ parathyroid detection system | Active comparator | Device: PTeye™ parathyroid detection systemPTeye™ assisted total thyroidectomy. PTeye will be used to identify the parathyroid glands early in the course of surgery. |
| Conventional total thyroidectomy | No intervention | –Total thyroidectomy without PTeye™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥18 years of age
- Undergoing total thyroidectomy, or completion total thyroidectomy
- Pre-operative serum adjusted calcium levels within normal ranges
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTeye™ parathyroid detection systemThe PTeye™ parathyroid detection system is an adjunctive tool to aid in the identification of visually suspected parathyroid tissue as granted by DEN17005. | Device | Total thyroidectomy with the PTeye™ parathyroid detection system |
Primary outcome
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
Time frame: 6 months
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %)
6 secondary outcomes
Rate of inadvertent parathyroidectomy (in %)
Time frame: within 4 weeks from operation
Rate of parathyroid auto-transplantation (in %)
Time frame: within operation
Day 0 PTH
Time frame: Post-operative Day 0
Day 1 Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative Day 1
3-month Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative 3 months
6-month Post-operative serum parathyroid hormone levels (pmol/L)
Time frame: Post-operative 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- BackgroundHospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2022-2023. 15:
- BackgroundHospital Authority HK Surgical Outcomes Monitoring & Improvement Programme (SOMIP) Report 2021-2022. 14:
- Background: PubMed 34116859Lui 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.
- Background: PubMed 24402815Edafe 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.
- Background: PubMed 4758544Payne RB, Little AJ, Williams RB, Milner JR. Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J. 1973 Dec 15;4(5893):643-6. doi: 10.1136/bmj.4.5893.643.
- Background: PubMed 31804401Solorzano CC, Thomas G, Baregamian N, Mahadevan-Jansen A. Detecting the Near Infrared Autofluorescence of the Human Parathyroid: Hype or Opportunity? Ann Surg. 2020 Dec;272(6):973-985. doi: 10.1097/SLA.0000000000003700.
- Background: PubMed 29122325Benmiloud 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.
- Background: PubMed 30710614Dip 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.
- Background: PubMed 31693081Benmiloud 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.
- Background: PubMed 31305127DiMarco A, Chotalia R, Bloxham R, McIntyre C, Tolley N, Palazzo FF. Does fluoroscopy prevent inadvertent parathyroidectomy in thyroid surgery? Ann R Coll Surg Engl. 2019 Sep;101(7):508-513. doi: 10.1308/rcsann.2019.0065. Epub 2019 Jul 15.
- Background: PubMed 26454675McWade 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.
- Background: PubMed 21721833Paras 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTeye™ parathyroid detection system in people with Hypocalcemia and Parathyroid, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Man Him, Matrix Fung, MBBS (+852 2255 4232, mmhfung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of significant post-operative hypoparathyroidism (SPH) after total thyroidectomy (in %) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07416149, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.