NCT02190825

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

July 9, 2014

Last Update Submit

November 21, 2023

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

  • Stage of pelvic floor prolapse as defined by POP-Q score

    6 months

  • Complications (SAE, AE)

    Up to 6 months

Interventions

NeuGuide deviceDEVICE

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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wolfson Medical Center

Bat Yam, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 15, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2016

Study Completion

October 30, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

IL(2)