Safety and Efficacy Study of the NeuGuide Device

N/ACompletedNCT02190825

Pop Medical Solutions15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

NeuGuide deviceDEVICE

The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Wolfson Medical Center

Bat Yam, Israel

Hadassah Medical Center

Jerusalem, Israel

Outcomes

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

Data from ClinicalTrials.gov

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