Investigative TechniquesNCT01848626
Study With Advanced Vaginal Tactile Imager
An observational study of Investigative Techniques, run by Artann Laboratories at 1 site in United States.
Trial summary
The objectives of this study are: 1. To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance; 2. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Investigative Techniques
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2014
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult females, presenting to the urogynecological office for a vaginal examination with normal pelvic floor organs, referred to gynecologic examination due to pelvic organ prolapse concern or earlier diagnosed with pelvic organ prolapse, will be considered eligible as volunteers to be enrolled in the clinical studies.
Who may be able to join
- Adult women (over the age of 21) falling within one of the following groups:
- No evidence of pelvic floor disorder and no prior pelvic surgery;
- Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Princeton Urogynecology
Princeton, New Jersey, 08540
About this study
The objectives of this study are:
- To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
- To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
- To test the data collection technique and establish a reliable examination procedure.
- Conditions
- Investigative Techniques
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging performance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Investigative TechniquesStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Egorov, PhD, Principal investigator, Artann Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848626
- Sponsor's protocol ID
- VTI 04
- Status last verified
- Jul 2014
- First submitted
- 3 May 2013
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.
PubMed 25344223
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study With Advanced Vaginal Tactile Imager
- ClinicalTrials.gov ID
- NCT01848626
- Acronym / sponsor ID
- VTI 04
- Conditions
- Investigative Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 May 2013 (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 objectives of this study are:
- To collect data necessary for assessing the performance of advanced Vaginal Tactile Imager (VTI) and evaluating the probe ergonomic design, safety and patient tolerance;
- To assess the clinical suitability of the interface software to facilitate the data collection process and to get in vivo examination data for validation of visualization and analysis routines;
- To test the data collection technique and establish a reliable examination procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females, presenting to the urogynecological office for a vaginal examination with normal pelvic floor organs, referred to gynecologic examination due to pelvic organ prolapse concern or earlier diagnosed with pelvic organ prolapse, will be considered eligible as volunteers to be enrolled in the clinical studies.
Key inclusion criteria (3 listed)
- No evidence of pelvic floor disorder and no prior pelvic surgery;
- Stage 1 or 2 pelvic organ prolapse affecting one or more vaginal compartment.
Key exclusion criteria (10 listed)
- 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;
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
Imaging performance
Time frame: 3 months
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 16 Jul 2014.
- Derived from this study: PubMed 25344223van Raalte H, Egorov V. Characterizing female pelvic floor conditions by tactile imaging. Int Urogynecol J. 2015 Apr;26(4):607-9. doi: 10.1007/s00192-014-2549-9. Epub 2014 Oct 25.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Investigative Techniques, run by Artann Laboratories at 1 site 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 10 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Imaging performance (time frame: 3 months). 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 NCT01848626, which also lists 1 linked publication.
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 16 Jul 2014.