Back to resultsSafety and Efficacy Study of the NeuGuide Device
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NeuGuide device
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility 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
Sites / Locations
- Wolfson Medical Center
- Hadassah Medical Center
Outcomes
Primary Outcome Measures
Stage of pelvic floor prolapse as defined by POP-Q score
Complications (SAE, AE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02190825
Brief Title
Safety and Efficacy Study of the NeuGuide Device
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pop Medical Solutions
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NeuGuide device
Intervention Description
The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor
Primary Outcome Measure Information:
Title
Stage of pelvic floor prolapse as defined by POP-Q score
Time Frame
6 months
Title
Complications (SAE, AE)
Time Frame
Up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Wolfson Medical Center
City
Bat Yam
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of the NeuGuide Device
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