Validation of Transvaginal Tactile Imaging (VTI-03)

• ClinicalTrials.gov Identifier: NCT01491334
• Recruitment Status: Completed
• First Posted: December 14, 2011
• Last Update Posted: February 25, 2014
• Sponsor: Artann Laboratories
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Artann Laboratories

Study Description

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.

Condition or disease
Pelvic Organ Prolapse

Detailed 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).

Study Design

• Study Type: Observational
• Actual Enrollment: 158 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: A Clinical Validation Study With Transvaginal Tactile Imaging
• Study Start Date: December 2011
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: November 2013

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. Effectiveness in assessment of the pelvic floor tissue conditions. [ Time Frame: Two years. ]
2. Ability in early detection of prolapse conditions. [ Time Frame: One Year ]
3. Ability in characterization of the outcome of pelvic floor reconstructive surgery. [ Time Frame: Two years. ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

The patient pool will comprise of 200 female patients.

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Princeton Urogynecology

Princeton, New Jersey, United States, 08540

United States, Pennsylvania

Institute of Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, United States, 18103

Sponsors and Collaborators

Artann Laboratories

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Vladimir Egorov, Ph.D.; Artann Laboratories, Inc.

More Information

Publications of Results:

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.

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.

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.

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.

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.

• Responsible Party: Artann Laboratories
• ClinicalTrials.gov Identifier: NCT01491334
• Other Study ID Numbers: VTI-03; 1R43AG034714 ( U.S. NIH Grant/Contract )
• First Posted: December 14, 2011
• Last Update Posted: February 25, 2014
• Last Verified: February 2014

Keywords provided by Artann Laboratories:

POP; Pelvic Floor; Pelvic Organ Prolapse

Additional relevant MeSH terms:

Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical