This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment neuguide device
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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Stage of pelvic floor prolapse as defined by POP-Q score
time frame: 6 months
Complications (SAE, AE)
time frame: Up to 6 months

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Pop Medical Solutions.