Development Study Using Vaginal Tactile Imager

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01111916

Enrollment

Registered

2010-04-28

Start date

2010-03-31

Completion date

2010-09-30

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results