Safety and Efficacy Study of the NeuGuide Device

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02190825

Enrollment

Registered

2014-07-15

Start date

2014-11-30

Completion date

2023-10-30

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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

Interventions

DEVICENeuGuide device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Stage of pelvic floor prolapse as defined by POP-Q score	6 months
Complications (SAE, AE)	Up to 6 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026