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NCT05022641 · OUTCOME

Average Number of Parathyroid Glands Identified

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy · Source last updated 2025-08-27

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
Measured within the procedure, generally not more than 2 hours

What was measured

Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the 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 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PTeye81
Standard of Care79

Reported measurements

Source class 1
Values in parathyroid glands per patient · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PTeye2.7Not reported2.42.9Not reported
Standard of Care2.6Not reported2.32.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .6
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .6
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        2.9
        value
        2.7
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        2.8
        value
        2.6
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      79
    units
    Participants
description
Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
MEAN
reporting Status
POSTED
time Frame
Measured within the procedure, generally not more than 2 hours
title
Average Number of Parathyroid Glands Identified
type
PRIMARY
unit Of Measure
parathyroid glands per patient

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice