Validation of Transvaginal Tactile Imaging

Pelvic Organ Prolapse Clinical Trial

— VTI-03  

Official title:

A Clinical Validation Study With Transvaginal Tactile Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491334
• Other study ID #: VTI-03
• Secondary ID: 1R43AG034714
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: February 24, 2014
• Start date: December 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.

2. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.

3. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.

4. The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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.

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. — View Citation

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness in assessment of the pelvic floor tissue conditions.		Two years.	Yes
Primary	Ability in early detection of prolapse conditions.		One Year	Yes
Primary	Ability in characterization of the outcome of pelvic floor reconstructive surgery.		Two years.	Yes