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NCT02190825 Clinical Trial

Safety and Efficacy Study of the NeuGuide Device

Pelvic Organ Prolapse Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02190825
Other study ID # CD0040
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date October 30, 2023

Study information
Verified date November 2023
Source Pop Medical Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 30, 2023
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Wolfson Medical Center Bat Yam
Israel Hadassah Medical Center Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Pop Medical Solutions

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stage of pelvic floor prolapse as defined by POP-Q score 6 months
Primary Complications (SAE, AE) Up to 6 months
See also
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Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A