| CTRI Number |
CTRI/2024/09/073766 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mapping Uterine Fibroids in reproductive age group of women using a novel software |
|
Scientific Title of Study
|
Evaluating the performance of FMRA for Uterine Fibroid Mapping |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CI-NESA-FMRA-02,version1.1,dated 20-Jun-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Puspam Upvan Prasutigruh Hospital |
| Address |
Puspam Upvan Prasutigruh Hospital
Department of Gynecology
Room No. 108-112,first floor,B Wing,
Upvan Comm,Centre,Nr Dhartinagar Bunglows,
Tragad Road, Chandkheda,
Ahmedabad,382424
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426499922 |
| Fax |
|
| Email |
pushpamgynec@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogitha Setty |
| Designation |
Chief Medical Affairs Lead |
| Affiliation |
Nesa Medtech Private Limited |
| Address |
Nesa Medtech Private Limited
15, 33rd Main 7th Block Bhavani Colony, Banashankari 3rd Stage,Banashankari,Bengaluru, Karnataka 560085
Bangalore
KARNATAKA
560085
India |
| Phone |
9019708139 |
| Fax |
|
| Email |
yogithas@nesamedtech.com |
|
Details of Contact Person
Public Query
|
| Name |
DT Arasu |
| Designation |
Director |
| Affiliation |
iDD Research Solutions INC |
| Address |
iDD Research Solutions INC
Plot no: 1&2, Kirti Nagar, Sector 15, Main Jharsa Road, Gurgaon, Haryana – 122001
Gurgaon
HARYANA
122001
India |
| Phone |
9962050483 |
| Fax |
|
| Email |
dtarasu@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Nesa MedTech Private Limited
15, 33rd Main 7th Block Bhavani Colony, Banashankari 3rd
Stage, Banashankari, Bengaluru, Karnataka 560085 |
|
|
Primary Sponsor
|
| Name |
Nesa MedTech Pvt Ltd |
| Address |
15, 33rd Main 7th Block Bhavani Colony, 33rd Main Rd, 7 Block, Banashankari 3rd Stage,Banashankari, Bengaluru,Karnataka 560085 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Triveni Kondareddy |
Asian Hospitals |
Gynecology Department,Ground floor,Room no.6
Near Anjaneya swamy temple, Vinukonda Road,Narasaraopet,Palanadu district,Andhra Pradesh,522601 India
Guntur
ANDHRA PRADESH |
9620682069
triveni.kondareddy@gmail.com |
| Dr Rathindranath Ray |
IPGME&RSSKM Hospital |
2nd Floor, Clinical Research Room,Ronalad Ross Building,IPGME&RSSKM Hospital,244,A.J.C Bose Road,Kolkata,West Bengal,700020
Kolkata
WEST BENGAL |
9831286320
rathindra24@yahoo.com |
| Dr Rashmi Yogish |
Khushi Fertility & IVF Centre |
Ground floor, OPD 1, No. 31, Mohan Chambers, 1st Main, Mini Forest Road, Jp Nagar 3rd Phase, Bangalore - 560078
Bangalore
KARNATAKA |
9008692449
rashmiyogish@gmail.com |
| DrVege Vishu Santhi |
Orizin Endocrine Centre |
Consultant Room No.1
Orizin Endocrine Centre,
Venkata Ratnam Street,
Suryaraopet, Vijayawada,Andhra Pradesh 520002
Krishna
ANDHRA PRADESH |
9848682231
ctuyalamanchi@gmail.com |
| Dr Mahesh Gupta |
Pushpam Upvam Prasutigruh Hospital |
Room No.108-112, first floor,B Wing, Upvan Comm.Centre,
Nr Dhartinagar Bunglows, Tragad Road, Chandkheda, Ahmedabad-382424
Ahmadabad
GUJARAT |
9426499922
pushpamgynec@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IPGMEandR Research Oversight Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Shakti Hospital Ethics Committee |
Approved |
| Vedanta Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Yalamanchi Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1)Women aged 21 and above diagnosed with symptomatic uterine fibroids and/scheduled for transvaginal imaging evaluation.
2)Women willing to provide written informed consent for utilizing related information. |
|
| ExclusionCriteria |
| Details |
1)Women in whom TVS cannot be done due to severe vaginismus/ vaginal stenosis.
2)Women with endometrial polyps.
3)Women with uterus size of above to 15cm.
4)FIGO classification type 0 and type 7.
5)Women who are pregnant.
6)Unmarried women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand FMRA usability related challenges |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the usability of FMRA in clinical decision support, through questionnaire and 3D model generated from FMRA. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
25/09/2024 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Uterine fibroids(leiomyomas) are common benign tumors, with a higher prevalence in the reproductive age group of women, although some women may develop fibroids at a younger age. They can cause abnormal uterine bleeding, pelvic pressure, bowel dysfunction, frequent urination and urgency, urinary retention, low back pain, constipation, and dyspareunia. 2D ultrasound images are used to diagnose fibroids routinely, however, identifying the exact location and volume of the fibroid with ultrasound images is often a challenge. This has been effectively addressed by the planning system named FMRA developed by Nesa MedTech Pvt.Ltd. FMRA post-processes 2D ultrasound images to a 3D rendered uterus model. Also, in the past FMRA has demonstrated strong positive correlation and excellent agreement with MRI in mapping of uterine fibroids, with minimal absolute variations. Thus, the current study targets to assess any real-world challenges in using FMRA software for mapping fibroids and also how the 3D-model can help improve informed-decision making. |