| CTRI Number |
CTRI/2025/10/095725 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate NexTemp® disposable thermometer against regular thermometers. |
|
Scientific Title of Study
|
A prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer against standard clinical thermometers (GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer) in real-world clinical settings. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MDIN/NXTO-02/PMCF-P/078 version 1.0 dated 09/May/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Bhatnagar |
| Designation |
Consulting Physician Cardiologist Diabetologist |
| Affiliation |
Abhinav Multispeciality Hospital Nagpur |
| Address |
Abhinav Multispeciality hospital Department of cardiologist & Diabetologist First Floor room no 2 10 no Puliya opposite Swastik School Lashkari Bagh Nagpur Maharashtra 440017
Nagpur
MAHARASHTRA
440017
India |
| Phone |
9823148978 |
| Fax |
|
| Email |
abhinavhospitalres13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Amandeep Kaur Sehmi |
| Designation |
Director - Clinical Operations |
| Affiliation |
Bioexcel Lifescience and Research LLP, Nagpur |
| Address |
Bioexcel Lifesciences and Research, Bioexcel Building, Plot No. 24, Vaibhavanand Society Godhni Road, Zingabai Takli, Nagpur, Maharashtra 440030
Nagpur
MAHARASHTRA
440030
India |
| Phone |
7030321095 |
| Fax |
|
| Email |
amankaur@bioexcelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs. Amandeep Kaur Sehmi |
| Designation |
Director - Clinical Operations |
| Affiliation |
Bioexcel Lifescience and Research LLP, Nagpur |
| Address |
Bioexcel Lifesciences and Research, Bioexcel Building, Plot No. 24, Vaibhavanand Society Godhni Road, Zingabai Takli, Nagpur, Maharashtra 440030
Nagpur
MAHARASHTRA
440030
India |
| Phone |
7030321095 |
| Fax |
|
| Email |
amankaur@bioexcelife.com |
|
|
Source of Monetary or Material Support
|
| Medical Indicators Inc 16 Thomas J. Rhodes Industrial Dr. Hamilton, NJ 08619 USA |
|
|
Primary Sponsor
|
| Name |
Medical Indicators Inc |
| Address |
16 Thomas J. Rhodes Industrial Dr.Hamilton,NJ 08619 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Bhatnagar |
Abhinav Multispeciality Hospital Nagpur |
10 no Puliya opposite Swastik School Lashkari Bagh Nagpur Maharashtra 440017
Nagpur
MAHARASHTRA |
9823148978
abhinavhospitalres13@gmail.com |
| Dr Shailesh Lute |
Swami Vivekanand medical mission hospital |
Swami Vivekanand Medical Mission Parsodi Khapri Khapri Nagpur Maharashtra 441108
Nagpur
MAHARASHTRA |
88795 23198
luteshailesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Jasleen hospitals ethics committee |
Approved |
| Jasleen hospitals ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Volunteers |
| Patients |
(1) ICD-10 Condition: A99||Unspecified viral hemorrhagic fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3.Welch Allyn Oral Digital Thermometer |
A battery-operated, reusable thermometer designed for sublingual (oral) temperature measurement. It provides a digital temperature reading typically within 4 to 180 seconds, depending on the setting mode, model and patient conditions. Accuracy depends on proper probe placement under the tongue and the use of single-use disposable probe covers to prevent cross-contamination. It is widely accepted as a reliable standard for non-invasive oral thermometry in clinical settings. |
| Comparator Agent |
GoodBaby Infrared Forehead (Non-Contact) Thermometer |
A handheld device that measures infrared radiation emitted from the forehead skin to estimate body temperature without physical contact It provides a temperature reading typically within 1 to 5 seconds It allows rapid screening particularly useful in high-throughput environments However its accuracy may be influenced by environmental conditions distance from the skin and surface characteristics such as sweat or cosmetics |
| Comparator Agent |
The Braun ThermoScan 4 Tympanic ear thermometer |
A device that measures infrared radiation from the tympanic membrane (eardrum) to estimate core body temperature It provides a temperature reading typically within 2 to 5 seconds. Correct placement in the external auditory canal and use of a sterile single use ear probe cover are essential for obtaining reliable readings Tympanic thermometers offer quick and non invasive measurements but may be affected by factors such as earwax small ear canals or improper angulation |
| Intervention |
The NexTemp GO F oral thermometer |
The NexTemp GO Oral Thermometer is a nonelectronic disposable medical device intended
for singleuse sublingual application. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 4 to 85 years.
2.Subjects undergoing routine body temperature measurement as part of standard medical care.
3.Subjects who are clinically stable and able to undergo non-invasive temperature measurement.
4.Subjects (or their legal guardians) who provide written informed consent (and assent, where applicable) prior to study participation.
5.Willing and able to comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with underlying medical conditions that could interfere with accurate temperature 2.measurement (eg severe infections, hypothermia or skin disorders at the measurement site
3.Recent exposure to external temperature influences such as hot/cold beverage consumption physical exertion or sweating within the last 30 minutes
4.Individuals with ear infections deformities or obstructions specific to tympanic thermometer use
Subjects currently taking antipyretic medications or undergoing treatments likely to affect body temperature within the past 4 hours
5.Subjects who are unable to cooperate with the measurement procedure eg crying infants 6.cognitively impaired adults without supervision
Participation in another clinical study that could interfere with study outcomes
7.Any other condition that, in the investigators opinion, may render the subject unsuitable for participation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate the accuracy of the NexTemp® Go Thermometer by comparing temperature readings with a reference thermometer. To assess the difference in body temperature readings (°C) between each device per subject. |
20 to 30 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the ease of use and handling characteristics of each thermometer as reported by clinical users.
2.To evaluate the performance of the thermometers under various environmental and patient conditions.
3.To determine the proportion of subjects classified as febrile by each device, based on a predefined fever threshold for example temperature equal to or higher than 37.5°C
4.To compare the time required to obtain a temperature reading using each device.
5.To collect usability ratings from healthcare personnel and adult subjects regarding comfort and ease of use of each thermometer.
6.To perform a safety assessment, including any reported adverse events related to device use discomfort during measurement, handling difficulties.
7.To document and evaluate any device malfunctions or operational issues encountered during the study. |
20 to 30 MIN |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Title: A prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer against standard clinical thermometers (GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer) in real-world clinical settings. This is a prospective, interventional, open-label, non-randomized, within-subjects comparative clinical study designed to evaluate the performance, safety, and usability of the NexTemp® Single-Use Thermometer as the primary investigational device, compared with three reference thermometers— GoodBaby Infrared non-contact Thermometer, The Braun ThermoScan 4 Tympanic ear thermometer, and Welch A oral digital thermometer — in real-world clinical settings. A total of 111 subjects, aged 4 to 85 years, will be enrolled. Each subject will participate in a single visit, during which body temperature will be measured sequentially using all four thermometers during a routine vital sign assessment. The duration of each measurement session will be approximately 5 to 10 minutes per subject. The sequence of device use will be standardized across all participants, and appropriate time intervals will be observed between measurements to reduce variability. Written informed consent (and assent where applicable) will be obtained from all participants or their legal guardians prior to participation. Data collected will include temperature readings from each device, time to obtain readings, user feedback from clinical personnel (and adult participants, where relevant), and any adverse events, device malfunctions, or usability concerns. Body temperature measurements will be performed sequentially using: 1. The Infra-Red (waiting 10-12 minutes will allow the skin temp to adjust to ambient and not represent the performance during normal standalone conditions when IR is the only device being used) 2. Tympanic (membrane temp is also impacted by external conditions, not as much as skin) 3. Oral (Welsh Allyn) and record time in the mouth to compare to Go 4. Oral (NXT Go) and record time in the mouth to confirm 10 seconds in the heat pocket.
|