Development Study Using Vaginal Tactile Imager

NCT01111916 | Completed

• 2 other identifiers: VTI 021R43AG034714-01
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (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.

  1 Year

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with normal pelvic anatomy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Artann Laboratories: lead
• National Institute on Aging (NIA): collaborator
• Princeton Healthcare System: collaborator

Study Sites (2)

Princeton Urogynecology

Princeton, New Jersey, 08542, United States

Location

Institute for Female Pelvic Medicine and Reconstructuve Surgery

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (5)

• 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.

  PMID: 22072417 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Egorov, PhD

  Artann Laboratories

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: April 28, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

US (2)