TriangleNCT05152927 · OUTCOME
Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 months after PTx procedure
What was measured
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.
Analysis population: Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.
Groups in this outcome
Parathyroid Eye (PTeye)
For participants 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.
Usual Standard of Care
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.
| Group | Source count |
|---|---|
| Parathyroid Eye (PTeye) | 29 |
| Usual Standard of Care | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parathyroid Eye (PTeye) | 0 | Not reported | Not reported | Not reported | Not reported |
| Usual Standard of Care | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- 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.
- groups
- description
- For participants 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.
- id
- OG000
- title
- Parathyroid Eye (PTeye)
- description
- 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.
- id
- OG001
- title
- Usual Standard of Care
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.
- reporting Status
- POSTED
- time Frame
- Up to 6 months after PTx procedure
- title
- Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice