Development Study Using Vaginal Tactile Imager

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

Completed

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

21 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Princeton Urogynecology, Princeton, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

National Institute on Aging (NIA)
Princeton Healthcare System

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Apr 28, 2010
Registry last updated: Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed