TriangleNCT04299425 · OUTCOME
Number of Frozen Sections Sent for Analysis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- frozen sections
- Interval / dispersion
- Not reported
- Time frame
- Immediate. During PTx procedure.
What was measured
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Groups in this outcome
NIRAF Detection Technology +
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
NIRAF Detection Technology -
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
| Group | Source count |
|---|---|
| NIRAF Detection Technology + | 80 |
| NIRAF Detection Technology - | 80 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NIRAF Detection Technology + | 13 | Not reported | Not reported | Not reported | Not reported |
| NIRAF Detection Technology - | 45 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 45
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 80
- units
- Participants
- description
- Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
- groups
- description
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- id
- OG000
- title
- NIRAF Detection Technology +
- description
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- id
- OG001
- title
- NIRAF Detection Technology -
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Immediate. During PTx procedure.
- title
- Number of Frozen Sections Sent for Analysis
- type
- SECONDARY
- unit Of Measure
- frozen sections
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice