Vaginal ProlapseNCT01190618
Surgical Outcomes of Vaginal Prolapse Repair With Elevate
An observational study of Vaginal Prolapse, run by Larry Sirls at 1 site in United States.
Trial summary
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. . Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginal Prolapse
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 31 Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women having vaginal repair with Elevate prolapse repair kit
Who may be able to join
- Women who have had a vaginal repair with Elevate prolapse repair kit
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .
Read the detailed description
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.
- Conditions
- Vaginal Prolapse
- Medical subject headings
- Uterine Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Outcomes
To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.
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 posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal 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
- Retrospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larry Sirls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Larry Sirls, Corewell Health East
- Investigators
- Larry Sirls, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190618
- Sponsor's protocol ID
- 2010-176
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2010
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Vaginal Prolapse Repair With the Elevate Prolapse Repair Kit
- ClinicalTrials.gov ID
- NCT01190618
- Acronym / sponsor ID
- 2010-176
- Conditions
- Vaginal Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Larry SirlsUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Aug 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 purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .
Detailed description
The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women having vaginal repair with Elevate prolapse repair kit
Key inclusion criteria (1 listed)
- Women who have had a vaginal repair with Elevate prolapse repair kit
Key exclusion criteria (1 listed)
- N/A
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
Comparison of Outcomes
Time frame: 3 Months
To evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Profift.
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 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Larry Sirls, MD principal investigator
Corewell Health East
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 Vaginal Prolapse, run by Larry Sirls 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 1 inclusion and 1 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 Feb 2017. 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?
Comparison of Outcomes (time frame: 3 Months). 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 16 Feb 2017.