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Trial record 2 of 2 for:    neuguide

Safety and Efficacy Study of the NeuGuide Device

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ClinicalTrials.gov Identifier: NCT02190825
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Pop Medical Solutions

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: NeuGuide device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: NeuGuide device
    The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190825


Locations
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Israel
Wolfson Medical Center
Bat Yam, Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Pop Medical Solutions

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Responsible Party: Pop Medical Solutions
ClinicalTrials.gov Identifier: NCT02190825     History of Changes
Other Study ID Numbers: CD0040
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: October 2015
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical