Safety and Efficacy Study of the NeuGuide Device | NCT02190825

Studies
Safety and Efficacy Study of the NeuGuide Device

NCT02190825

Sponsor

Pop Medical Solutions

Status

Completed

Last Update Posted

Nov 22, 2023Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

NeuGuide device

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Oct 30, 2023Actual

First Submitted Date

Jul 9, 2014

First Submission Date that Met QC Criteria

Jul 13, 2014

First Posted Date

Jul 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 22, 2023Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NeuGuide device	Device	The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson Medical Center		Bat Yam			Israel
Hadassah Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided