Pelvic Organ ProlapseNCT01134003
A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System
An observational study of Pelvic Organ Prolapse, run by The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania at 1 site in United States.
Trial summary
retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- 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
- Child, Adult, Older adult
Study population: women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift
Who may be able to join
- women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
About this study
retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Gynecare Prolift, Pelvic organ prolapse, forming a large database of women who have recieve Gynecare prolift system
- Medical subject headings
- Pelvic Organ Prolapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJan 2008
- Primary completionNov 2009
- Study completionDec 2009
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
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134003
- Sponsor's protocol ID
- SLHN 2007-98
- Status last verified
- May 2010
- First submitted
- 27 May 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System
- ClinicalTrials.gov ID
- NCT01134003
- Acronym / sponsor ID
- SLHN 2007-98
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Gynecare Prolift, Pelvic organ prolapse, forming a large database of women who have recieve Gynecare prolift system
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 May 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.
retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift
Key inclusion criteria (1 listed)
- women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift
Key exclusion criteria (1 listed)
- none
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
Not reported in the source record.
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 May 2010.
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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.
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, run by The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania 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 31 May 2010. 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.
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 31 May 2010.