TriangleNCT05022641 · OUTCOME
Number of Frozen Sections
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
- Immediate
What was measured
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.
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 | 81 |
| Standard of Care | 79 |
Reported measurements
0 frozen sections taken
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 49 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care | 47 | Not reported | Not reported | Not reported | Not reported |
1 or more frozen sections taken
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 32 | Not reported | Not reported | Not reported | Not reported |
| Standard of Care | 32 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .6
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- .6
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 47
- title
- 0 frozen sections taken
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 32
- title
- 1 or more frozen sections taken
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 79
- units
- Participants
- description
- 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.
- 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Immediate
- title
- Number of Frozen Sections
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice