Validation of Transvaginal Tactile Imaging (VTI-03)
|ClinicalTrials.gov Identifier: NCT01491334|
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : February 25, 2014
|Condition or disease|
|Pelvic Organ Prolapse|
- 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).
|Study Type :||Observational|
|Actual Enrollment :||158 participants|
|Observational Model:||Case Control|
|Official Title:||A Clinical Validation Study With Transvaginal Tactile Imaging|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||November 2013|
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.
- Effectiveness in assessment of the pelvic floor tissue conditions. [ Time Frame: Two years. ]
- Ability in early detection of prolapse conditions. [ Time Frame: One Year ]
- Ability in characterization of the outcome of pelvic floor reconstructive surgery. [ Time Frame: Two years. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491334
|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.|