| 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
|
|
|
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
|
|
|
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
|