Development Study Using Vaginal Tactile Imager

Pelvic Organ Prolapse Clinical Trial

Official title:

A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111916
• Other study ID #: VTI 02
• Secondary ID: 1R43AG034714-01
• Status: Completed
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2024
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine and Reconstructuve Surgery	Allentown	Pennsylvania
United States	Princeton Urogynecology	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA), Princeton Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. 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. — View Citation

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, 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 Year