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
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Princeton Healthcare System
Investigators
Principal Investigator: Vladimir Egorov, PhD Artann Laboratories
  More Information

Publications:
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.
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.

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: February 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014