Health Condition 1: R877- Abnormal histological findings inspecimens from female genital organs
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ,Bloated,Uncomfortable Urination). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assess and record the ease of usage of GYIDE system 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 2. To record the region of ablation and no damage to the serosa | — |
Countries
India
Contacts
Public ContactSudhir Patel
Nesa Medtech Private Limited
Outcome results
None listed