A study on determining the safety of GYIDE in fibroid uterus specime
Not Applicable
- Conditions
- Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
- Registration Number
- CTRI/2023/02/050132
- Lead Sponsor
- esa Medtech Pvt Ltd
- 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 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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method