NCT05022641 · OUTCOME
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 5-14 days after surgery
What was measured
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.
Analysis population: 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.
Groups in this outcome
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.
Standard of Care
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
| Group | Source count |
|---|---|
| PTeye | 52 |
| Standard of Care | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 23 | 26.9 | Not reported | Not reported | Not reported |
| Standard of Care | 25.3 | 23.4 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .65
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .65
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26.9
- value
- 23
- group Id
- OG001
- spread
- 23.4
- value
- 25.3
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- 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.
- dispersion Type
- Standard Deviation
- groups
- description
- 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.
- id
- OG000
- title
- PTeye
- description
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- id
- OG001
- title
- Standard of Care
- param Type
- MEAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- 5-14 days after surgery
- title
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
- type
- SECONDARY
- unit Of Measure
- pg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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