Validation of Transvaginal Tactile Imaging (VTI-03)
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.
Pelvic Organ Prolapse
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Clinical Validation Study With Transvaginal Tactile Imaging|
- Effectiveness in assessment of the pelvic floor tissue conditions. [ Time Frame: Two years. ] [ Designated as safety issue: Yes ]
- Ability in early detection of prolapse conditions. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- Ability in characterization of the outcome of pelvic floor reconstructive surgery. [ Time Frame: Two years. ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2011|
|Study Completion Date:||November 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Asymptomatic women presenting at various ages without prolapse condition.
Symptomatic women presenting with prolapse conditions with no prior surgeries and women presenting with surgery scheduled with or without prior surgery.
- The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
- The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
- The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
- 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).
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|United States, Pennsylvania|
|Institute of Female Pelvic Medicine and Reconstructive Surgery|
|Allentown, Pennsylvania, United States, 18103|
|Principal Investigator:||Vladimir Egorov, Ph.D.||Artann Laboratories, Inc.|