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OpenTrials
Completed

NCT Number: NCT02190825

Safety and Efficacy Study of the NeuGuide Device

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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson Medical Center, Bat Yam, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuGuide device

Device

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

Primary outcomes

  1. Stage of pelvic floor prolapse as defined by POP-Q score

    Time frame: 6 months

  2. Complications (SAE, AE)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Pop Medical Solutions

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2023
First posted
Jul 15, 2014
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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