Pelvic Organ ProlapseNCT01111916
Development Study Using Vaginal Tactile Imager
An observational study of Pelvic Organ Prolapse, run by Artann Laboratories at 2 sites in United States.
Trial summary
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women with normal pelvic anatomy
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Female Pelvic Medicine and Reconstructuve Surgery
Allentown, Pennsylvania, 18103
Princeton Urogynecology
Princeton, New Jersey, 08542
About this study
Official title: A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.
Read the detailed 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.
- Conditions
- Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Princeton Healthcare System
- Responsible party
- Sponsor
- Investigators
- Vladimir Egorov, PhD, Principal investigator, Artann Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111916
- Sponsor's protocol ID
- VTI 02
- Other IDs
- 1R43AG034714-01
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2010
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22072417Egorov 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. Vaginal tactile imaging: clinical results. Proceedings of the 10th International Tissue Elasticity Conference, Arlington, Texas, Oct 12-15, 2011: 66.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue
- ClinicalTrials.gov ID
- NCT01111916
- Acronym / sponsor ID
- VTI 02
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Princeton Healthcare System
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with normal pelvic anatomy
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Results publication: PubMed 22072417Egorov 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.
- Results publicationEgorov 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.
- Results publicationEgorov 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.
- Results publicationvan 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.
- Results publicationvan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Egorov, PhD principal investigator
Artann Laboratories
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Artann Laboratories at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01111916, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.