| CTRI Number |
CTRI/2017/03/008128 [Registered on: 17/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
17/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate Enhanced Visual Assessment System in detecting cervical cancer |
|
Scientific Title of Study
|
To evaluate a low –cost efficient and effective Enhanced Visual Assessment System developed by Mobile ODT on the basis of ease of use, affordability, increased revenue to offset cost and patient / provider satisfaction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renuka Matti |
| Designation |
Preventive Oncology Consultant |
| Affiliation |
Dr. L H Hiranandani Hospital |
| Address |
Room 714
Executive Health Check Up Department
7th Floor
Dr. L H Hiranandani Hospital, Hill Side Avenue, Hiranandani Gardens, Powai
Mumbai (Suburban)
MAHARASHTRA
Mumbai 4000076
India |
| Phone |
9867056359 |
| Fax |
|
| Email |
drrenumatti61@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dior DSa |
| Designation |
Manager - Operations |
| Affiliation |
International Oncology Services Pvt Ltd |
| Address |
International Oncology Office
Room 1
Oncology Department
Basement Floor
International Oncology Services Pvt Ltd
Dr. L H Hiranandani Hospital
Powai
Mumbai (Suburban)
MAHARASHTRA
Mumbai – 400076
India |
| Phone |
9920099156 |
| Fax |
|
| Email |
dior.kara@iosplcancer.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vibhav Gupta |
| Designation |
Senior Manager - Operations |
| Affiliation |
International Oncology Services Pvt Ltd |
| Address |
International Oncology Office
Room 1
Oncology Department
Basement Floor
International Oncology Services Pvt Ltd
Dr L H Hiranandani Hospital
Powai
Mumbai (Suburban)
MAHARASHTRA
Mumbai – 400076
India |
| Phone |
8879585666 |
| Fax |
|
| Email |
vibhav.gupta@iosplcancer.com |
|
|
Source of Monetary or Material Support
|
| Mobile ODT,
Ben Avigdor 8,
Floor 3,
Tel Avvi 64165,
Israel |
|
|
Primary Sponsor
|
| Name |
Mobile ODT Mobile Optical Detection Technologies |
| Address |
Mobile ODT,
Ben Avigdor 8,
Floor 3,
Tel Avvi 64165,
Israel |
| Type of Sponsor |
Other [Pvt Company (ISO Certified) ] |
|
|
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 Rakhee Sahu |
Dr L H Hiranandani Hospital |
OPD 05
Ground Floor
Dr L H Hiranandani HospitalPowai
Mumbai 400076
Mumbai (Suburban)
MAHARASHTRA |
9820194413
rakhee.sahu@hiranandanihospital.org |
| Dr Renuka Matti |
Dr L H Hiranandani Hospital |
Room 714
Executive Health Check Up
7th Floor
Dr L H Hiranandani Hospital
Hill Side Avenue
Hiranandani Gardens
Powai
Mumbai 400076
Mumbai (Suburban)
MAHARASHTRA |
9867056359
drrenumatti61@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. L H Hiranandnai Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cervical Cancer screening |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Able to understand and consent to participating in the study |
|
| ExclusionCriteria |
| Details |
Women previously detected with cervical cancer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients detected with cervical cancer / precancerous reasons |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Provider and patient satisfaction with EVA System, consistent with utilization of the device |
6 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
01/03/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a non randomized, observational screening study to detect cervical cancer using the low cost and effective Enhanced Visual Assesment System (EVA System) developed by Mobile ODT. - This system is a low cost system comprised of 3 elements –
- The scope which is Mobile, lightweight, and durable medical device for magnified inspection that includes an ultra-bright light source with glare-reducing cross-polarization technology, a lens enabling up to 17 times magnification for superior imaging, and a rechargeable battery for up to 10 hours of continuous examinations.
- The app- Mobile phone based application allowing confidential data capture and review, remote expert decision support and patient engagement through image review.
- The Portal: An online quality control, measurement and evaluation system facilitating screening, consultation, and program level analytic review from anywhere in the world.
The system is attempting to better the gold standard of PAP smear by introducing digital cervicography an advanced cervical cancer screening method, into primary screening, thus exploring the technology’s ability to reduce loss to follow up and provide easy care diagnosis. A sample size of 1500-2000 patients will be taken during this study. During the study, using the EVA system, the patients detected with cervical cancer / precancerous conditions will be measured as will the patients detected with cervical cancer / precancerous conditions having negative initial screening results (PAP smear / HPV are –ve) will be measured. The provider and patient satisfaction will also be measured. There are numerous studies attempting to better the cervical cancer screening with regards to better sensitivity and specificity. If found to be successful, this study will help us significantly raise the standards of cervical screening |