Safety and Efficacy Study of the NeuGuide Device
Not Applicable
Completed
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT02190825
- Lead Sponsor
- Pop Medical Solutions
- Brief Summary
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP).
Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system.
Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- Women ages 18-80 years old
- POP-Q stage III prolapse or higher
- Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device
- Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol
- No exclusion criteria fulfilled
Exclusion Criteria
- Diagnosis of reproductive tract anomalies
- Prior pelvic radiation therapy or any malignancy
- Inability to complete written questionnaires.
- Women with significant Pelvic Inflammatory Disease (PID) history
- Women with known allergy to Nickel or Nitinol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Stage of pelvic floor prolapse as defined by POP-Q score 6 months Complications (SAE, AE) Up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Wolfson Medical Center
🇮🇱Bat Yam, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel