TriangleNCT05579782 · OUTCOME
Overall Average Number of Parathyroid Glands Identified With High Confidence.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Number of parathyroid glands
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Immediate (during total thyroidectomy, up to 3 hours)
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
NIRAF Detection Technology (+)
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). 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. Other Name: PTeye Device
NIRAF Detection Technology (-)
Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
| Group | Source count |
|---|---|
| NIRAF Detection Technology (+) | 39 |
| NIRAF Detection Technology (-) | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NIRAF Detection Technology (+) | 3.4 | Not reported | 3.2 | 3.7 | Not reported |
| NIRAF Detection Technology (-) | 2.9 | Not reported | 2.5 | 3.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.2
- upper Limit
- 3.7
- value
- 3.4
- group Id
- OG001
- lower Limit
- 2.5
- upper Limit
- 3.2
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 41
- 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
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). 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. Other Name: PTeye Device
- id
- OG000
- title
- NIRAF Detection Technology (+)
- description
- Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- id
- OG001
- title
- NIRAF Detection Technology (-)
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Immediate (during total thyroidectomy, up to 3 hours)
- title
- Overall Average Number of Parathyroid Glands Identified With High Confidence.
- type
- SECONDARY
- unit Of Measure
- Number of parathyroid glands
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice