Safety and Efficacy Study of the NeuGuide Device

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02190825
• Date of registration: 09/07/2014
• Prospective Registration: Yes
• Primary sponsor: Pop Medical Solutions
• Public title: Safety and Efficacy Study of the NeuGuide Device
• Date of first enrolment: November 2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02190825
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic Organ Prolapse

Intervention(s)

Device: NeuGuide device

Primary Outcome(s)

Stage of pelvic floor prolapse as defined by POP-Q score [Time Frame: 6 months]

Complications (SAE, AE) [Time Frame: Up to 6 months]

Secondary ID(s)

CD0040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors