ParathyroidNCT04560426
Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
A study testing Intraoperative parathyroid gland auxiliary recognition system in people with Parathyroid and Intraoperative Monitoring, run by Fudan University at 1 site in China.
Trial summary
This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Parathyroid, Intraoperative Monitoring, Thyroid Cancer
- What is being tested?
- Intraoperative parathyroid gland auxiliary recognition system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
- No history of neck surgery and radiotherapy.
- There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
- No abnormal calcium metabolism disease.
- No abnormalities in blood calcium and blood PTH before operation.
- No allergy to contrast agents.
- The patient or his agent signs an informed consent statement.
Who cannot join
- Does not meet the entry criteria;
- Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
About this study
This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.
- Conditions
- Parathyroid, Intraoperative Monitoring, Thyroid Cancer
- Being tested
- Intraoperative parathyroid gland auxiliary recognition system
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative parathyroid gland auxiliary recognition systemDevice
The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.
| Study group | Role | What they receive |
|---|---|---|
| Naked eyes & Instrument assistance | Experimental | Identify the parathyroid glands through the experience of surgeons and assistance of instrument. Receives: Device: Intraoperative parathyroid gland auxiliary recognition system |
| Naked eyes only | No intervention | Identify the parathyroid glands only through the experience of surgeons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Calcium level
Patients' serum Calcium level at 24 hours after surgery.
Measured: 24 hours after surgery
Serum Calcium level
Patients' serum Calcium level at 1 month after surgery.
Measured: 1 month after surgery
PTH
Patients' serum PTH level at 24 hours after surgery.
Measured: 24 hours after surgery
PTH
Patients' serum PTH level at 1 month after surgery.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start31 Oct 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParathyroidStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560426
- Sponsor's protocol ID
- PTIOP1.0
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
- ClinicalTrials.gov ID
- NCT04560426
- Acronym / sponsor ID
- PTIOP1.0
- Conditions
- Parathyroid, Intraoperative Monitoring, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 23 Sep 2020 (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 intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naked eyes & Instrument assistance | Experimental | Device: Intraoperative parathyroid gland auxiliary recognition systemIdentify the parathyroid glands through the experience of surgeons and assistance of instrument. |
| Naked eyes only | No intervention | –Identify the parathyroid glands only through the experience of surgeons. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
- No history of neck surgery and radiotherapy.
- There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
- No abnormal calcium metabolism disease.
- No abnormalities in blood calcium and blood PTH before operation.
Key exclusion criteria (2 listed)
- Does not meet the entry criteria;
- Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
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 |
|---|---|---|
| Intraoperative parathyroid gland auxiliary recognition systemThe enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system. | Device | Naked eyes & Instrument assistance |
Primary outcome
Serum Calcium level
Time frame: 24 hours after surgery
Patients' serum Calcium level at 24 hours after surgery.
Serum Calcium level
Time frame: 1 month after surgery
Patients' serum Calcium level at 1 month after surgery.
PTH
Time frame: 24 hours after surgery
Patients' serum PTH level at 24 hours after surgery.
PTH
Time frame: 1 month after surgery
Patients' serum PTH level at 1 month after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative parathyroid gland auxiliary recognition system in people with Parathyroid and Intraoperative Monitoring, run by Fudan University at 1 site in China.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, Doctor (+86 13817311886, neck130@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Calcium level (time frame: 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2020.