Validation of Transvaginal Tactile Imaging

NCT01491334 | Completed

• 2 other identifiers: VTI-031R43AG034714
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.

Conditions

Pelvic Organ Prolapse

Keywords

POP; Pelvic Floor; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• Effectiveness in assessment of the pelvic floor tissue conditions.

  Two years.

• Ability in early detection of prolapse conditions.

  One Year

• Ability in characterization of the outcome of pelvic floor reconstructive surgery.

  Two years.

Study Arms (2)

Asymptomatic

Asymptomatic women presenting at various ages without prolapse condition.

Symptomatic

Symptomatic women presenting with prolapse conditions with no prior surgeries and women presenting with surgery scheduled with or without prior surgery.

Eligibility Criteria

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

Study Population

The patient pool will comprise of 200 female patients.

You may qualify if:

• Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
• No evidence of pelvic organ prolapse and no prior pelvic surgery
• Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
• Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled

You may not qualify if:

• Active skin infection or ulceration within the vagina
• Presence of a vaginal septum;
• Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
• Ongoing radiation therapy for pelvic cancer;
• Impacted stool
• Recent (less than three months) pelvic surgery;
• Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
• Severe hemorrhoids
• Surgically absent rectum or bladder
• Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician

Sponsors & Collaborators

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

Study Sites (2)

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Institute of Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18103, United States

Location

Related Publications (5)

• Sarvazyan A, Egorov V. Mechanical Imaging - a Technology for 3-D Visualization and Characterization of Soft Tissue Abnormalities. A Review. Curr Med Imaging Rev. 2012 Feb 1;8(1):64-73. doi: 10.2174/157340512799220571.

  PMID: 24058326 RESULT

• van Raalte H, Egorov V, Lucente V, Murphy M, Saiz C. 3D tactile imaging in early prolapse detection. International Continence Society 43rd Annual Meeting. Barcelona, Spain, 26-30 August, 2013.

  RESULT

• Egorov V, van Raalte H, Lucente V. Tactile imaging and tissue elasticity as a marker of pelvic floor conditions. International Urogynecological Association: 38th Annual Meeting, Dublin, Ireland, May 28-June 1, 2013.

  RESULT

• van Raalte H, Lucente V, Egorov V. Measuring outcome in urogynecological surgery by 3-D tactile imaging: First clinical experience. International Urogynecological Association: 38th Annual Meeting, Dublin, Ireland, May 28-June 1, 2013.

  RESULT

• van Raalte H, Egorov V, Lucente V. Tissue elasticity as a marker of pelvic floor conditions: Clinical results. Proceedings of the 11th International Tissue Elasticity Conference, Deauville, France, October 2-5, 2012: 46.

  RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Vladimir Egorov, Ph.D.

  Artann Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: December 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

US (2)