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Development Study Using Vaginal Tactile Imager

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ClinicalTrials.gov Identifier: NCT01111916
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):

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

Condition or disease
Pelvic Organ Prolapse

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.

Study Design

Study Type : Observational
Actual Enrollment : 31 participants
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
Study Start Date : March 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult women with normal pelvic anatomy

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111916

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
Principal Investigator: Vladimir Egorov, PhD Artann Laboratories
More Information

Egorov V, Patel M, Sarvazyan AP. Vaginal tactile imager for direct tissue elasticity modulus estimation. Proceedings of the 10th International Tissue Elasticity Conference, Arlington, Texas, October 12-15, 2011:59.
Egorov V, van Raalte H, Lucente V. Vaginal tactile imaging: clinical results. Proceedings of the 10th International Tissue Elasticity Conference, Arlington, Texas, Oct 12-15, 2011: 66.
van Raalte H, Lucente V, Egorov V. 3-D imaging and quantifying vaginal tissue elasticity under normal and prolapse conditions. International Urogynecological Association: 36th Annual Meeting, Lisbon, Portugal, June 28 - July 2, 2011.
van Raalte H, Egorov V, Lucente V. Tactile imaging of pelvic floor changes with age and parity. American Urogynecologic Society: 32nd Annual Scientific Meeting, Providence, Rhode Island, September 14-17, 2011.

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01111916     History of Changes
Other Study ID Numbers: VTI 02
1R43AG034714-01 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical