A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue

Artann Laboratories2 sites in 1 country31 target enrollmentMarch 2010

ConditionsPelvic Organ Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Artann Laboratories
Enrollment: 31
Locations: 2
Primary Endpoint: 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.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

September 2010

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Artann Laboratories

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 1 Year