FindTrial
Sign In

A study on determining the safety of GYIDE in fibroid uterus specimen

A study on ultrasound-guided radiofrequency ablation on ex vivo uterus fibroid with GYIDE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050132
Enrollment
16
Registered
2023-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women aged 35 to 60 years undergoing hysterectomy due to fibroid with FIGO types 2,3, 4, 5 and 2â??5 (â??transmuralâ?¿) . 2. Intact uterus specimen ( no damage to the uterus). 3. Uterus sizes from 8 cm to 15 cm

Exclusion criteria

Exclusion criteria: 1. Presence of a single polyp >= 1.5 cm, or multiple polyps of any size 2. Presence of cervical fibroids. 3. Any abnormality of the endometrial cavity that obstructs access of the handpiece

Design outcomes

Primary

MeasureTime frame
To estimate the number of ablated fibroid which does not have thermal spread 6mm away from margins of RFA ablation. Visual Gross inspection of uterus and serosa for any perforationTimepoint: At baseline only—

Secondary

MeasureTime frame
To check the ease of maneuvering GYIDE into the uterus specimen.Timepoint: At baseline—

Countries

India

Contacts

Public ContactSreekar Kothamachu

Nesa Medtech Pvt Ltd

lakshmi@nesamedtec.com8073659428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026