Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2024/07/070536
CTRI/2024/07/070536
Not yet recruiting
Phase 3

ltrasound-guided transvaginal radiofrequency ablation of uterine fibroids performance evaluation of GYIDE - NI

esa Medtech Private Limited0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Sponsor
esa Medtech Private Limited
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
esa Medtech Private Limited

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
ltrasound guided radiofrequency ablation of fibroids using GYIDE System
CTRI/2023/05/052627esa Medtech Private Limited
Recruiting
Not Applicable
se of transvaginal non-ablative Radiofrequency in the Treatment of Urinary Incontinence and Vaginal Atrophy
RBR-6g8mjzkniversidade de Caxias do Sul - UCS
Not yet recruiting
Not Applicable
se of new technologies for the treatment of vaginal sequelae caused by radiotherapy.
RBR-2x4hqmFaculdade de Medicina da Universidade Federal do Rio Grande do Sul
Not yet recruiting
Not Applicable
Radiofrequency within the vagina in the treatment of involuntary urine loss: Randomized clinical trialrinary incontinenceC12.777.934.852
RBR-9wfww5Programa de Pós-Graduação em Gerontologia Biomédica da Pontifícia Universidade Católica do Rio Grande do Sul
Not yet recruiting
Not Applicable
Effect of the heat transmitted by a waves device for the treatment of vulvar lichen sclerosusvulvar lichen sclerosus - response of treatmentsN00-N99
RBR-10z85rczFaculdade de Medicina da Universidade Federal do Rio Grande do Sul