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CTRI Number  CTRI/2024/07/070536 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Interventional study with GYIDE system for ablation of fibroids under ultrasound guidance.  
Scientific Title of Study   Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids performance evaluation of GYIDE 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIl  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopinath P M 
Designation  Professor & HOD 
Affiliation  Kauvery Hospital 
Address  8th floor, fertility center 225A 23 1 Arcot Rd Ottagapalayam Kannika Puram, Vadapalani Chennai Tamil Nadu

Chennai
TAMIL NADU
600026
India 
Phone  9840888878  
Fax    
Email  pmgnath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sreekar Kothamachu 
Designation  CEO & Director 
Affiliation  Nesa Medtech Private Limited 
Address  cellar floor, 15, 33rd Main 7th Block Bhavani Colony Banashankari 2 stage Bangalore

Bangalore
KARNATAKA
560085
India 
Phone  9019708139  
Fax    
Email  sreekar@nesamedtech.com  
 
Details of Contact Person
Public Query
 
Name  Lakshmi Bai P 
Designation  Product Lead 
Affiliation  Nesa Medtech Pvt Ltd 
Address  cellar floor, 15, 33rd Main 7th Block Bhavani Colony Banashankari 2 stage Bangalore

Bangalore
KARNATAKA
560098
India 
Phone  8892614430  
Fax    
Email  lakshmi@nesamedtech.com  
 
Source of Monetary or Material Support  
Nesa Medtech Pvt Ltd 15, 33rd Main 7th Block Bhavani Colony, 33rd Main Rd, 7 Block, Banashankari 3rd Stage, Bengaluru, Karnataka 560085  
 
Primary Sponsor  
Name  Nesa Medtech Private Limited 
Address  15, 33rd Main 7th Block Bhavani Colony, Banashankari 3rd Stage, Bengaluru, Karnataka 560085  
Type of Sponsor  Other [Medical device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mamatha S  JSS Hospital  Groud floor, OBGYN OPD,Mahatma Gandhi Road, Mysuru, Karnataka 570004
Mysore
KARNATAKA 
9845047939

mamathas@jssuni.edu.in 
Dr Gopinath P M  Kauvery Hospital   8th floor, Fertility center 225A, 23/1, Arcot Rd, Ottagapalayam, Kannika Puram, Vadapalani, Chennai, Tamil Nadu 600026,
Chennai
TAMIL NADU 
9840888878

pmgnath@gmail.com 
Dr Savitha C  Vani Vilas Hospital,Bangalore Medical College & Research Institute   Fort Road KR Market Bangalore -560002
Bangalore
KARNATAKA 
9844089168

savithakushu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College & Research Institute  Approved 
JSS Medical College  Approved 
Kauvery Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Radiofrequency ablation for uterine fibroid using GYIDE  GYIDE: GYIDE is intended for processing diagnostic ultrasound imaging to provide planning and positional guidance for transcervical treatment of symptomatic uterine fibroids. The maximum intervention duration is 20-30 min prior to hysterectomy  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1.Women in reproductive age who have completed family planning with symptomatic uterine fibroid (menorrhagia, heavy menstrual bleeding) for at least 2 months and as confirmed by USG.
2.Patients presenting with 1-4 fibroids of FIGO types 2, 3, 4, and/or type 2-5, with diameter of 1.0 cm and up-to 6.0 cm.
3.No desire for future fertility
4.Women willing to provide informed consent for participation in the study and willing to undergo this RFA using (GYIDE) and adhere to follow-up requirements
 
 
ExclusionCriteria 
Details  1.Presence of a single polyp less than 1.5 cm, or multiple polyps of any size, within the uterine cavity.
2.Any abnormality of the endometrial cavity that obstructs access of the handpiece
3.Total uterine volume more than 1000 cc.
4.Pregnancy.
5.Presence of type 0 fibroids, unless greater than 1 cm in diameter.
6.Presence of an extrauterine pelvic mass that has not been diagnosed as benign.
7.Multiple uterine scars.
8.Congenital uterine abnormality
9.Previous procedure for fibroids or heavy menstrual bleeding other than myomectomy (example: endometrial ablation).
10.Confirmed abdominal or pelvic malignancy within the previous five years
11.Active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia, UTI.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The main aim of this study is to evaluate the device ability to ablate the fibroid while avoiding damage to serosa or surrounding organs.  1.To capture the serosa in the hysterectomized specimens(visit 1- day of procedure).
2.To evaluate the ablated region of target fibroid(visit 1- day of procedure).
 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the total time required for GYIDE procedure  To record the time for mapping of fibroids(visit 1- day of procedure).
To record the time required for ablation for each of the fibroids(visit 1- day of procedure).
 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2024 
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="6"
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 women who are aged between 35 to 50 years, 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. Normally, 2D ultrasound images are used to diagnose fibroids. 
Ultrasonography(US)-guided transvaginal (TVS) radiofrequency ablation (RFA) in the treatment of fibroids that can be performed without the need for any abdominal cut or multiple incisions like that of existing laparotomy and laparoscopy procedures. Placement of Radiofrequency ablation (RFA) electrodes into the fibroid under ultrasound guidance and manually maneuvering to all the locations is an extremely skilled procedure. Further, there is no guidance/reference for the force required in piercing the fibroid with the RFA electrode since the texture of fibroids differs significantly. Another important aspect is fibroid Mapping: Identifying the exact location and volume of the fibroid with ultrasound images is often a challenge. Thus there are challenges in treating the fibroid just with the radiofrequency electrode and existing 2D ultrasound images This has been effectively addressed by the planning system and navigation arm by Nesa MedTech, through GYIDE.
The purpose of this study is to assess the performance of the GYIDE device that helps in processing diagnostic ultrasound imaging to provide planning and positional guidance for transvaginal approach for delivering radiofrequency ablation

 
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