ClinicalTrials.Veeva

Menu

Safety and Efficacy Study of the NeuGuide Device

P

Pop Medical Solutions

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: NeuGuide device

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No 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

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems