Development Study Using Vaginal Tactile Imager

Artann Laboratories

Status: Completed

Conditions: Pelvic Organ Prolapse

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01111916

VTI 02

1R43AG034714-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. no evidence of pelvic organ prolapse and no prior pelvic surgery
2. stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments
3. no evidence of pelvic organ prolapse with prior pelvic surgery (with or without the use of graft material)

Exclusion criteria

1. patients with active skin infection, tissue breakdown or ulceration
2. patients with abnormal vaginal anatomy, including vaginal septum, history of vaginal/pelvic radiation, presence of a vaginal tumor or lesion
3. recent pelvic surgery with less than 3-month interval from surgery