NCT01491334

Validation of Transvaginal Tactile Imaging

A Clinical Validation Study With Transvaginal Tactile Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Artann Laboratories · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Pelvic Organ Prolapse

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2011-12-14
• Last updated: 2014-02-25

Locations

2 sites across 1 country: United States