CystectomyNCT00969514
Robotic-Assisted Laparoscopic Cystectomy
An observational study of Cystectomy, run by Corewell Health East at 1 site in United States.
Trial summary
Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystectomy
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing robotic cystectomy
Who may be able to join
- Patients undergoing robotic cystectomy at Beaumont Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic-assisted Laparoscopic Cystectomy: Our Center's Clinical Experience
Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences.
Read the detailed description
Robotic Cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Our objective is to investigate our results from this novel procedure.
- Conditions
- Cystectomy
- Keywords
- Robotic cystectomy, Bladder
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 |
|---|---|---|
| Robotic cystectomy | Patients undergoing robotic laparoscopic cystectomy at Beaumont Hospital-RO |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystectomyStudies 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Don BUI, MD, Principal investigator, Beaumont Hospitals-RO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969514
- Sponsor's protocol ID
- 2009-167
- Status last verified
- Sep 2011
- First submitted
- 31 Aug 2009
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Laparoscopic Cystectomy: Our Center's Clinical Experience
- ClinicalTrials.gov ID
- NCT00969514
- Acronym / sponsor ID
- 2009-167
- Conditions
- Cystectomy
- Keywords
- Robotic cystectomy, Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Sep 2009 (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.
Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences.
Detailed description
Robotic Cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Our objective is to investigate our results from this novel procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic cystectomy | – | –Patients undergoing robotic laparoscopic cystectomy at Beaumont Hospital-RO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing robotic cystectomy
Key inclusion criteria (1 listed)
- Patients undergoing robotic cystectomy at Beaumont Hospital
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 3 Oct 2011.
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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.
Don BUI, MD principal investigator
Beaumont Hospitals-RO
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 Cystectomy, run by Corewell Health East 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 3 Oct 2011. 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 3 Oct 2011.