Safety and Efficacy Study of the NeuGuide Device

Pop Medical Solutions

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: NeuGuide device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02190825

CD0040

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)