Skip to main content
OpenTrials
Completed

NCT Number: NCT01111916

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

Looking for future studies?

Notify Me

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

Loading trial locations.

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

  1. 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.

Related clinical trials

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