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Validation of Transvaginal Tactile Imaging — VTI-03  

Pelvic Organ Prolapse Clinical Trial

Official title:
A Clinical Validation Study With Transvaginal Tactile Imaging

Clinical Trial Summary

The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.

Clinical Trial Description

1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.

2. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.

3. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.

4. The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women). ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01491334
Study type Observational
Source Artann Laboratories
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date November 2013
View Details
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