An interventional study of Parathyroid Eye (PTeye) in Parathyroid Diseases, Parathyroid Dysfunction and Parathyroid Neoplasms, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.
PRIMARY OBJECTIVES:
I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.
II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.
III. Assess the impact of PTeye on minimizing risk of post-surgical complications.
Participants will be randomized to either the experimental or control arm.
The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not.
For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Participants will be follow-ed up for up to 6 months after surgery.
54 studies on the registry are indexed under Parathyroid Diseases; 6 are open to participants now.
This study's enrollment of 79 is below the median of 90 across 32 interventional studies indexed under Parathyroid Diseases.
Browse Parathyroid Diseases studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For patients assigned to the study arm, 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.
Device: Parathyroid Eye (PTeye)
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Intraoperative Tool
Also known as: Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
Time frame: At the end of the parathyroidectomy, up to 5 hours
Number of Participants With Persistent Hyperparathyroidism (Immediate)
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
Time frame: 5-14 days after PTx procedure
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)
Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
Time frame: 5-14 days after PTx procedure
Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
Time frame: Up to 6 months after PTx procedure
Number of Parathyroid Glands (PG) Identified
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent
The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration Taken to Identify First Parathyroid Gland
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
Time frame: During parathyroidectomy, up to 5 hours
Median Duration Taken to Identify Last Parathyroid Gland
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration of Parathyroidectomy (PTx) Procedure
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
Time frame: Up to 5 hours
Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize
Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Nights in the Hospital After Parathyroidectomy
Median number of nights spent in the hospital post-surgery is defined as having spent \<= 23 hours (0 nights) or \> 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.
Time frame: 0-72 hours after PTx procedure
Median Number of 'False Positive' Tissue Samples Excised by Surgeon
The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
Time frame: Up to 10 days after PTx procedure
Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions
Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.
Time frame: Up to 6 months after PTx procedure
Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)
Time frame: From 6 - 12 months after PTx procedure
| Milestone | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Started | 38 | 41 |
| Completed | 38 | 41 |
| Not completed | 0 | 0 |
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
| frozen aspirate samples | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis | 0 (0 to 1) | 0 (0 to 1) |
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
| Participants | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Participants With Persistent Hyperparathyroidism (Immediate) | 0 | 1 |
Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
| Participants | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient) | 0 | 0 |
If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
| Participants | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy) | 0 | 1 |
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
| parathyroid glands | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Parathyroid Glands (PG) Identified | 45 | 45 |
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
| parathyroid glands | Parathyroid Eye (PTeye) |
|---|---|
| Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only) | 1 (1 to 2) |
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
| parathyroid glands | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Intra-operatively | 1 (1 to 2) | 1 (0 to 2) |
| Localized pre-operatively | 1 (1 to 3) | 1 (1 to 3) |
The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab
| assays | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent | 5 (4 to 8) | 5 (4 to 12) |
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
| minutes | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Duration Taken to Identify First Parathyroid Gland | 38 (15 to 154) | 31 (11 to 184) |
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
| minutes | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Duration Taken to Identify Last Parathyroid Gland | 48 (16 to 224) | 35 (11 to 184) |
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
| minutes | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Duration of Parathyroidectomy (PTx) Procedure | 87 (34 to 243) | 82 (26 to 296) |
Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L
| minutes | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize | 76 (27 to 243) | 66 (38 to 150) |
Median number of nights spent in the hospital post-surgery is defined as having spent \<= 23 hours (0 nights) or \> 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.
| number of nights | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| <= 23 hours | 0 (0 to 0) | 0 (0 to 0) |
| > 23 hours | 1 (1 to 1) | 1 (1 to 1) |
The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
| tissue samples | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Median Number of 'False Positive' Tissue Samples Excised by Surgeon | 0 (0 to 0) | 0 (0 to 0) |
Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.
| participants | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions | 5 | 8 |
Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)
| Participants | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure | 0 | 1 |
Collected over Up to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parathyroid Eye (PTeye) | 0/38 (0%) | 2/38 (5.3%) | 0/38 (0%) |
| Usual Standard of Care | 0/41 (0%) | 5/41 (12.2%) | 0/41 (0%) |
| Event | Parathyroid Eye (PTeye) | Usual Standard of Care |
|---|---|---|
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/38 | 0/41 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/38 | 0/41 |
| FractureInjury, poisoning and procedural complications | 0/38 | 1/41 |
| Pericardial effusionCardiac disorders | 0/38 | 1/41 |
| SyncopeNervous system disorders | 0/38 | 1/41 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps), Other - specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/38 | 1/41 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/38 | 1/41 |
| Age, Continuous(years) | Parathyroid Eye (PTeye) | Usual Standard of Care | Total |
|---|---|---|---|
| Median | 68 (25 to 87) | 64 (39 to 81) | 67 (25 to 87) |
| Sex: Female, Male(Participants) | Parathyroid Eye (PTeye) | Usual Standard of Care | Total |
|---|---|---|---|
| Female | 27 | 30 | 57 |
| Male | 11 | 11 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Parathyroid Eye (PTeye) | Usual Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 37 | 36 | 73 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Parathyroid Eye (PTeye) | Usual Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 2 | 2 | 4 |
| White | 27 | 27 | 54 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 8 | 12 |
| Region of Enrollment(participants) | Parathyroid Eye (PTeye) | Usual Standard of Care | Total |
|---|---|---|---|
| United States | 38 | 41 | 79 |
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