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Credibility of Ultrasound Detection of Female Genital Prolapse Mesh

NCT06000215 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-08-22

No results posted yet for this study

Summary

The aim of the study is to investigate the credibility of ultrasound in detection of synthetic polypropylene vaginal implants. In detail, the study investigates if the ultrasound examiner experience and the standard method of examination may affect the detection of synthetic polypropylene vaginal implants by ultrasound.

The primary hypothesis is if 90% of prolapse mesh could be detected by the ultrasound examiners who are blinded to the previous prolapse surgery, the ultrasound is credible for prolapse mesh detection.

The secondary hypothesis is if the ultrasound detection is not significantly different between the ultrasound examiners, the method of ultrasound examination is mandatory to acheive credible ultrasound detection of the prolapse mesh.

Conditions

  • Ultrasound Therapy; Complications

Interventions

DIAGNOSTIC_TEST

Perineal/introital ultrasound examination, two different examiners. The examiners are blinded to each other and to the previous prolapse surgery.

Each examiner to answer: 1. Is there a mesh or not: Yes or No 2. If Yes: * Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh * What is the length of the mesh in a single midsagittal view image 3. Examination record time is to be registered.

DIAGNOSTIC_TEST

Perineal/introital ultrasound examination, two different examiners. The examiners is now being informed of the previous prolapse surgery.

Each examiner to answer: 1. Is there a mesh or not: Yes or No 2. If Yes: * Which type of mesh? Uphold, Pinnacle Posterior or Artisyn® Y-Shaped Mesh * What is the length of the mesh in a single midsagittal view image 3. Examination record time is to be registered.

Sponsors & Collaborators

Principal Investigators

  • Edward Morcos, MD, PhD · Karolinska Institutet - Danderyds Sjukhus (KIDS)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-21
Primary Completion
2018-12-21
Completion
2018-12-21
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000215 on ClinicalTrials.gov