Development Study Using Vaginal Tactile Imager
Completed
- Conditions
- Pelvic Organ Prolapse
- Registration Number
- NCT01111916
- Lead Sponsor
- Artann Laboratories
- Brief Summary
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.
- Detailed Description
Pelvic organ prolapse affects 40-50% of women in US. This study aims to establish a reliable examination procedure, collect data necessary for assessing the performance of Vaginal Tactile Imaging sensors, assess clinical suitability of interface software and correlate elasticity measurements with clinical examination findings for normal versus prolapse conditions of the female pelvis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 31
Inclusion Criteria
- no evidence of pelvic organ prolapse and no prior pelvic surgery
- stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
- no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)
Exclusion Criteria
- patients with active skin infection, tissue breakdown or ulceration
- patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
- recent pelvic surgery with less than 3-month interval from surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether there is a detectable difference in 3-D elasticity images provided by Vaginal Tactile Imager for the patients with presence or absence of prolapse. 1 Year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Princeton Urogynecology
🇺🇸Princeton, New Jersey, United States
Institute for Female Pelvic Medicine and Reconstructuve Surgery
🇺🇸Allentown, Pennsylvania, United States