Interventional study with GYIDE system for ablation of fibroids under ultrasound guidance.

Phase 3

• Conditions: Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle

• Registration Number: CTRI/2024/07/070536
• Lead Sponsor: esa Medtech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

11.Active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia, UTI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified