Development Study Using Vaginal Tactile Imager

This study has been completed.
Sponsor:
Collaborators:
Princeton Healthcare System
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01111916
First received: March 22, 2010
Last updated: February 24, 2014
Last verified: February 2014

March 22, 2010
February 24, 2014
March 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01111916 on ClinicalTrials.gov Archive Site
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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

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Adult women with normal pelvic anatomy

Pelvic Organ Prolapse
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Egorov V, van Raalte H, Lucente V. Quantifying vaginal tissue elasticity under normal and prolapse conditions by tactile imaging. Int Urogynecol J. 2012 Apr;23(4):459-66. doi: 10.1007/s00192-011-1592-z. Epub 2011 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01111916
VTI 02, 1R43AG034714-01
No
Artann Laboratories
Artann Laboratories
  • National Institute on Aging (NIA)
  • Princeton Healthcare System
Principal Investigator: Vladimir Egorov, PhD Artann Laboratories
Artann Laboratories
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP