NCT05022667 · OUTCOME
Number of Frozen Section Analysis Performed.
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
- Collected immediately following surgery
What was measured
Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
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 total thyroidectomy procedure. 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, as per device functionality requirements.
Standard of Care
The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
| Group | Source count |
|---|---|
| PTeye | 57 |
| Standard of Care | 57 |
Reported measurements
0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 55 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care | 55 | Not reported | Not reported | Not reported | Not reported |
1 or more
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 2 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 55
- title
- 0
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- title
- 1 or more
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
- 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 total thyroidectomy procedure. 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, as per device functionality requirements.
- id
- OG000
- title
- PTeye
- description
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- id
- OG001
- title
- Standard of Care
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Collected immediately following surgery
- title
- Number of Frozen Section Analysis Performed.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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