Pelvic Organ ProlapseNCT01463462
Electronic Catheter Stethoscope
An observational study of Pelvic Organ Prolapse and Gynecologic Cancers, run by University of South Florida at 1 site in United States.
Trial summary
This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Gynecologic Cancers, Uterine Leiomyomata
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Current patients having gynecological surgery
Who may be able to join
- age 18 or older
- plan to have one of the following types of surgery:
- laparoscopic or abdominal gynecological surgery
- vaginal surgery
- able to provide written informed consent
Who cannot join
- under 18 years of age
- bilateral tubal ligation as the single reason for surgery
- current pregnancy
- unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Center Operating Rooms at the Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.
- Conditions
- Pelvic Organ Prolapse, Gynecologic Cancers, Uterine Leiomyomata, Adenomyosis, Endometrial Hyperplasia, Other Abnormal Uterine and Vaginal Bleeding
- Medical subject headings
- Pelvic Organ Prolapse, Myofibroma, Adenomyosis, Endometrial Hyperplasia, Uterine Hemorrhage, Pelvic Pain
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 |
|---|---|---|
| Electronic Catheter Stethoscope | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder and ureter sounds during pelvic surgery.
Measured: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Secondary outcomes (1)
changes from baseline bladder and ureteral function sounds
Measured: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Hart, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463462
- Sponsor's protocol ID
- USF IRB 00001841
- Status last verified
- May 2016
- First submitted
- 19 Oct 2011
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT01463462
- Acronym / sponsor ID
- USF IRB 00001841
- Conditions
- Pelvic Organ Prolapse, Gynecologic Cancers, Uterine Leiomyomata, Adenomyosis, Endometrial Hyperplasia, Other Abnormal Uterine and Vaginal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Nov 2011 (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.
This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Catheter Stethoscope | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Current patients having gynecological surgery
Key inclusion criteria (5 listed)
- age 18 or older
- plan to have one of the following types of surgery:
- able to provide written informed consent
Key exclusion criteria (4 listed)
- under 18 years of age
- bilateral tubal ligation as the single reason for surgery
- current pregnancy
- unable to provide written informed consent
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
bladder and ureter sounds during pelvic surgery.
Time frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
1 secondary outcome
changes from baseline bladder and ureteral function sounds
Time frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)
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 27 May 2016.
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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.
Stuart Hart, MD principal investigator
University of South Florida
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 Pelvic Organ Prolapse and Gynecologic Cancers, run by University of South Florida 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 5 inclusion and 4 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 27 May 2016. 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?
bladder and ureter sounds during pelvic surgery. (time frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2016.