| CTRI Number |
CTRI/2025/03/082617 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to check how accurate the AViTA Infrared Ear Thermometer is in measuring temperature. |
|
Scientific Title of Study
|
Clinical Accuracy Study of the AViTA Infrared Ear Thermometer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-AGCR-001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaibhav Kothari |
| Designation |
Principal Investigator |
| Affiliation |
Navneet Memorial Hospital Sushrusha |
| Address |
OPD Room, Ground Floor, Navneet Memorial Hospital Sushrusha, Opp. Sardar Patel Seva Samaj Hall, Navrangpura, Ahmedabad-380009, Gujarat, India.
Ahmadabad
GUJARAT
380009
India |
| Phone |
9979700995 |
| Fax |
|
| Email |
drvaibhavkotharicr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 322, 3rd Floor, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad-380054, Gujarat, India.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Shende |
| Designation |
Chief Executive Officer |
| Affiliation |
Akshar Global Clinical Research Private Limited |
| Address |
Akshar Global Clinical Research Private Limited, 322, 3rd Floor, Shreeya Amalga, Avalon Hotel Cross Road, Thaltej, Ahmedabad-380054, Gujarat, India.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9978078056 |
| Fax |
|
| Email |
mangesh.shende@agcro.com |
|
|
Source of Monetary or Material Support
|
| eInfoChips Pvt. Ltd, Block – E, Ratna, 3rd Eye Voice, Village: Ognaj, Taluka; Daskroi, Ahmedabad – 380060, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
eInfoChips Pvt. Ltd. |
| Address |
eInfoChips Pvt. Ltd., Block – E, Ratna, 3rd Eye Voice, Village: Ognaj, Taluka; Daskroi, Ahmedabad – 380060, Gujarat, India. |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhav Kothari |
Navneet Memorial Hospital Sushrusha |
OPD Room, Ground floor, Navneet Memorial Hospital Sushrusha , Opp. Sardar Patel Seva Samaj Hall , Navrangpura , Ahmedabad , Gujarat-380009 , India.
Ahmadabad
GUJARAT |
9979700995
drvaibhavkotharicr@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Navneet Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
afebrile subjects |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AViTA Infrared Ear Thermometer (Test Device) |
The AViTA Infrared Ear Thermometer is a hand-held, battery-powered, non-sterile, reusable, infrared thermometer that converts a user’s ear temperature, using the infrared energy emitted by the tympanic membrane and surrounding ear canal to an oral equivalent temperature |
| Comparator Agent |
Braun® IRT6520 Ear Thermometer (Comparator device) |
The Braun ThermoScan® Ear thermometer has been carefully developed for accurate, safe, and fast temperature measurements in the ear.
The shape of the thermometer probe prevents it from being inserted too far into the ear canal, which can hurt the eardrum. However, as with any thermometer, proper technique is critical to obtaining accurate temperatures. Therefore, read the instructions carefully and thoroughly. |
| Comparator Agent |
Welch Allyn® Braun ThermoScan® PRO 6000 Ear Thermometer (Reference device) |
The Braun Thermoscan® PRO 6000 Ear thermometer is indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participant will be eligible for inclusion in this study only if all of the following criteria meets.
1. Children of age more than 1 month to less than 18 years or Male and female participants of age 18 years or above
2. Participants with an afebrile condition 97 degree Fahrenheit or 36.1 Celsius to 99 degree Fahrenheit or 37.2 Celsius or Participants with a febrile condition 99.5 degree Fahrenheit or 37.5 Celsius or above.
3. Participants LAR Parents or Legal Guardian who are willing and able to comply with the protocol requirement for the duration of the study examinations.
4. Participants, LAR, Parents or Legal Guardian who are willing to provide informed consent or assent form participants 7 to 17 years of age to participate in the study. |
|
| ExclusionCriteria |
| Details |
Participant will not be eligible for inclusion in this study if any of the following criteria meets:
1. Pre-term new-born babies (babies born before 37 weeks of gestation) or small-for-gestational age newborn babies (newborn baby, born at 37 weeks or later, with a weight below the 10th percentile for new-born babies of the same gestational age)
2. Participant with an acute life-threatening infection
3. Participant with an anatomical abnormality that affects temperature measurement
4. Participant with blood or drainage in the external ear canal
5. Participant wearing a hearing aid (Participant may be included if the hearing aid is removed 20 minutes prior to testing and throughout the examination)
6. Participant who has used ear drops within 8 hours prior to testing
7. Participant with ear diseases (such as ear infection, acute or inflammatory condition such as swimmer’s ear, an obstruction in which the tympanic membrane cannot be visualized or excess cerumen build-up.)
8. Participant with traumatic injuries
9. Any other condition that, in the investigator’s judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective:
To gather temperature measurements from study participants in an adaptive manner with the AViTA Infrared Ear Thermometer, in conjunction with temperature measurements of the study participants taken with the “Gold Standard” / reference device, the Welch Allyn® Braun ThermoScan® PRO 6000 Ear Thermometer, for the purposes of research and development of the AViTA Infrared Ear Thermometer. |
Baseline
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
To gather temperature measurements from study participants in an adaptive manner with the AViTA Infrared Ear Thermometer, in conjunction with temperature measurements of the study participants taken with the “Gold Standard” / reference device, the Welch Allyn® Braun ThermoScan® PRO 6000 Ear Thermometer, for the purposes of research and development of the AViTA Infrared Ear Thermometer. This is a single day, single visit study. After obtaining informed consent, the investigator will conduct the study related screening procedures like medical/medication history, demographic data (date of birth, gender, race, ethnicity, weight, height and body mass index etc.) recording and physical examination. Participants who fulfil all the inclusion/exclusion criteria will be eligible for the study. The participant will be allowed to stabilize for a period of twenty (20) minutes before temperature measurements, especially if they come from a different environmental temperature than that in which the thermometers are stored. Timing will be monitored as part of the data collection. The sequence of use of 3 devices will be as per randomization schedule. The measurement of body temperature of each participant will be performed by keeping a minimum 1-minute interval between thermometer readings. Each thermometer will be held at the opening of ear canal for a period of 5 to 10 seconds. The measurement of body temperature of each device will be recorded once only.
|