Safety and Efficacy Study of the NeuGuide Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2023-10-30

Brief Summary

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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

Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NeuGuide device

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

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wolfson Medical Center

Bat Yam, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CD0040

Identifier Type: -

Identifier Source: org_study_id