Development Study Using Vaginal Tactile Imager

This study has been completed.

Sponsor:

Collaborators:

National Institute on Aging (NIA)

Princeton Healthcare System

Information provided by (Responsible Party):

Artann Laboratories

ClinicalTrials.gov Identifier:

NCT01111916

First received: March 22, 2010

Last updated: November 29, 2011

Last verified: February 2011

History of Changes

Purpose

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

Condition
Pelvic Organ Prolapse

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Artann Laboratories:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	March 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adult women with normal pelvic anatomy

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111916

Locations

United States, New Jersey
Princeton Urogynecology
Princeton, New Jersey, United States, 08542
United States, Pennsylvania
Institute for Female Pelvic Medicine and Reconstructuve Surgery
Allentown, Pennsylvania, United States, 18103

Sponsors and Collaborators

Artann Laboratories

National Institute on Aging (NIA)

Princeton Healthcare System

Investigators

Principal Investigator:

Vladimir Egorov, PhD

Artann Laboratories

More Information

Publications:

Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. Int Urogynecol J. 2011 Nov 10; [Epub ahead of print]

Responsible Party:	Artann Laboratories
ClinicalTrials.gov Identifier:	NCT01111916 History of Changes
Other Study ID Numbers:	VTI 02, 1R43AG034714-01
Study First Received:	March 22, 2010
Last Updated:	November 29, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013

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