Safety and Efficacy Study of the NeuGuide Device
This trial is active, not recruiting.
|Condition||pelvic organ prolapse|
|Sponsor||Pop Medical Solutions|
|Start date||November 2014|
|End date||April 2016|
|Trial size||15 participants|
|Trial identifier||NCT02190825, CD0040|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Stage of pelvic floor prolapse as defined by POP-Q score
time frame: 6 months
Complications (SAE, AE)
time frame: Up to 6 months
Female participants from 18 years up to 80 years old.
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
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