Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Radiofrequency ablation for
uterine fibroid using GYIDE: GYIDE: GYIDE is intended for
processing diagnostic
ultrasound imaging to provide
planning and positional
guidance for transcervi
Sponsors
Nesa Medtech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main aim of this study is to evaluate the device ability to ablate the fibroid while avoiding damage to serosa or surrounding organs.Timepoint: 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
| Measure | Time frame |
|---|---|
| To determine the total time required for GYIDE procedureTimepoint: 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). | — |
Countries
India
Contacts
Public ContactLakshmi Bai P
Nesa Medtech Private Limited
Outcome results
None listed