Status:
COMPLETED
Safety and Efficacy Study of the NeuGuide Device
Lead Sponsor:
Pop Medical Solutions
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 prolaps...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02190825
Start Date
November 1 2014
End Date
October 30 2023
Last Update
November 22 2023
Active Locations (2)
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1
Wolfson Medical Center
Bat Yam, Israel
2
Hadassah Medical Center
Jerusalem, Israel