Pelvic Organ ProlapseNCT02294383
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
An observational study of Pelvic Organ Prolapse, run by Artann Laboratories at 2 sites in United States.
Trial summary
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in… 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
- Pelvic Organ Prolapse
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Jan 2016
- 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: The study population comprises of patients referred to a gynecologist/urogynecologist for either regular examination or with a pelvic floor organ concern.
Who may be able to join
- No prior pelvic floor surgery, and
- Normal pelvic floor conditions, or
- POP Stage I affecting one or more vaginal compartment, or
- POP Stage II affecting one or more vaginal compartment, or
- POP Stage III affecting one or more vaginal compartment, or
- POP Stage IV 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;
- Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
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- Severe hemorrhoids;
- Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
- Current pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Princeton Urogynecology
Princeton, New Jersey, 08540
About this study
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Biomechanics, Tissue Elasticity, Tactile Imaging
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre/post surgery pelvic floor assessment | Not described | |
| Conservative treatmen monitoring | Not described | |
| Pelvic floor muscle contrictions | Not described | |
| Imaging reproducibility | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
Measured: From 1 day to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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-control
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294383
- Sponsor's protocol ID
- VTI05
- Other IDs
- R44AG034714
- Status last verified
- Jun 2018
- First submitted
- 14 Nov 2014
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans Biomed Eng. 2010 Jul;57(7):1736-44. doi: 10.1109/TBME.2010.2045757. Epub 2010 May 17.
PubMed 20483695Egorov 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 22072417van 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 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
- ClinicalTrials.gov ID
- NCT02294383
- Acronym / sponsor ID
- VTI05
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Biomechanics, Tissue Elasticity, Tactile Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Nov 2014 (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 clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre/post surgery pelvic floor assessment | – | – |
| Conservative treatmen monitoring | – | – |
| Pelvic floor muscle contrictions | – | – |
| Imaging reproducibility | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises of patients referred to a gynecologist/urogynecologist for either regular examination or with a pelvic floor organ concern.
Key inclusion criteria (6 listed)
- No prior pelvic floor surgery, and
- Normal pelvic floor conditions, or
- POP Stage I affecting one or more vaginal compartment, or
- POP Stage II affecting one or more vaginal compartment, or
- POP Stage III affecting one or more vaginal compartment, or
Key exclusion criteria (9 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
Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm
Time frame: From 1 day to 12 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 7 Jun 2018.
- Background: PubMed 20483695Egorov V, van Raalte H, Sarvazyan AP. Vaginal tactile imaging. IEEE Trans Biomed Eng. 2010 Jul;57(7):1736-44. doi: 10.1109/TBME.2010.2045757. Epub 2010 May 17.
- Background: 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.
- Background: 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.
The record lists no contact. Use the official record to reach the sponsor.
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 6 inclusion and 9 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 7 Jun 2018. 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?
Tissue elasticity measured as a gradient in tactile image. Unit of Measure: kPa/mm (time frame: From 1 day to 12 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 NCT02294383, which also lists 3 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 7 Jun 2018.