ltrasound guided radiofrequency ablation of fibroids using GYIDE System
Not Applicable
- Conditions
- Health Condition 1: R877- Abnormal histological findings inspecimens from female genital organs
- Registration Number
- CTRI/2023/05/052627
- Lead Sponsor
- esa Medtech Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Women aged 35 to 60 years subjected to hysterectomy due to fibroid with FIGO types 2, 3, 4, 5 and 2-5(transmural)
2. Women willing to provide informed consent for participation in the study and willing to undergo this RFA for fibroid using (GYIDE)
Exclusion Criteria
1. Presence of a single polyp? 1.5cm or multiple polyps of any size.
2. Presence of more than 4 fibroids and fibroid with diameter > 5.0cm
3. One or more clinically relevant fibroids that are significantly calcified.
4. Any abnormality of the endometrial cavity that obstructs access of the handpiece
5. Total uterine volume > 1000cc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the safety issues associated with the usage of GYIDE system.Timepoint: To assess the presence of any adverse events during the 15 days post surgery (Fever,Bleeding, BowelMovement,Vomiting,Nausea <br/ ><br>,Bloated,Uncomfortable Urination).
- Secondary Outcome Measures
Name Time Method 1. Assess and record the ease of usage of GYIDE system <br/ ><br>2. Screening the hysterectomy specimen for any unintended perforation and determining the ablation zone.Timepoint: 1. To record the ease of using GYIDE system on a scale of 0 to 5 <br/ ><br>2. To record the region of ablation and no damage to the serosa