TriangleNCT05022667 · OUTCOME
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- parathyroid glands per patient
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Immediate (During total thyroidectomy procedure)
What was measured
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTeye | 3.1 | Not reported | 2.8 | 3.3 | Not reported |
| Standard of Care | 2.9 | Not reported | 2.6 | 3.2 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 3.3
- value
- 3.1
- group Id
- OG001
- lower Limit
- 2.6
- upper Limit
- 3.2
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
- dispersion Type
- 95% Confidence Interval
- 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
- MEAN
- reporting Status
- POSTED
- time Frame
- Immediate (During total thyroidectomy procedure)
- title
- The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
- type
- PRIMARY
- unit Of Measure
- parathyroid glands per patient
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice