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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA212147-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Cancer Institute (NCI) | NIH |
| Vanderbilt University | OTHER |
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This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.
Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTeye | Experimental | The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery. |
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| Standard of Care | Other | The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTeye | Device | The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Parathyroid Glands Identified | Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye. | Measured within the procedure, generally not more than 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage. | 5-14 days after surgery |
| Appropriate Intraoperative Parathyroid Hormone Drop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gauger | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40668552 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PTeye | The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2021 |
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Only participants will be masked to the intervention
| Standard of Care | Other | The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
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>50% drop from baseline at 10 minutes post-resection |
| baseline to 10 minutes |
| Duration of Surgery | Surgery duration in minutes | Measured within the procedure, generally not more than 2 hours |
| Number of Nights Spent in the Hospital After Parathyroidectomy | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. | 0-72 hours after PTx procedure. |
| Number of Frozen Sections | Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted. | Immediate |
| FG001 | Standard of Care | The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
| COMPLETED | Participants were considered to have completed the trial if data was collected from them for the primary outcome measure. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PTeye | The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements. |
| BG001 | Standard of Care | The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Final Diagnosis | Diagnosis was determined after undergoing procedure. | Count of Participants | Participants |
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| Preoperative PTH (pg/mL) | Mean | Standard Deviation | pg/mL |
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| Preoperative calcium (pg/dL) | Mean | Standard Deviation | pg/dL |
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| Preoperative vitamin D (mcg) | Mean | Standard Deviation | mcg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Average Number of Parathyroid Glands Identified | Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye. | Posted | Mean | 95% Confidence Interval | parathyroid glands per patient | Measured within the procedure, generally not more than 2 hours |
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| Secondary | Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage. | Not all participants returned for this lab assessment during the 5-14 day data collection period. As such, no data for these participants was collected. | Posted | Mean | Standard Deviation | pg/mL | 5-14 days after surgery |
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| Secondary | Appropriate Intraoperative Parathyroid Hormone Drop | >50% drop from baseline at 10 minutes post-resection | Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame. | Posted | Count of Participants | Participants | baseline to 10 minutes |
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| Secondary | Duration of Surgery | Surgery duration in minutes | Posted | Mean | Standard Deviation | minutes | Measured within the procedure, generally not more than 2 hours |
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| Secondary | Number of Nights Spent in the Hospital After Parathyroidectomy | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. | Posted | Count of Participants | Participants | 0-72 hours after PTx procedure. |
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| Secondary | Number of Frozen Sections | Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted. | Posted | Count of Participants | Participants | Immediate |
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Up to 6-months after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTeye | The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG001 | Standard of Care | The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. | 0 | 79 | 0 | 79 | 0 | 79 |
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The relatively small sample size may miss rare events such as operative failure. Additionally, inter-variability amongst the two surgeons and their surgical approaches adds more complexity. Lastly, these findings may only be generalizable to higher volume centers with more experienced surgeons.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Gauger | University of Michigan | 734-936-0231 | pgauger@med.umich.edu |
| Aug 7, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 5, 2021 | Aug 7, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| D006934 | Hypercalcemia |
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D006961 | Hyperparathyroidism |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Asian |
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| Other |
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| Recurrent/persistent hyperparathyroidism |
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| Other |
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