Prostate and Kidney CancerPhase 1/2NCT02136121
Prospective Investigation of Robotic Single-port System
A Phase 1/2 study testing da Vinci Sp Surgical System - Robotic in people with Prostate and Kidney Cancer, run by Intuitive Surgical at 1 site in France.
Trial summary
To determine the feasibility of representative urologic procedures as measured by the rate of conversions Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate and Kidney Cancer
- What is being tested?
- da Vinci Sp Surgical System - Robotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Oct 2013
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostatectomy:
- Patients age 18-75 years
- BMI <=35 kg/m2
- Confirmed localized adenocarcinoma of the prostate
- Suitable for minimally invasive prostate cancer surgery
- Nephrectomy:
Show all 10Show fewer
- Patient age 18-75 years
- BMI <=35 kg/m2
- Kidney disease amenable to nephrectomy or partial nephrectomy
- Suitable for minimally invasive kidney surgery
Who cannot join
- Untreated active infection (includes local kidney infection)
- Vulnerable population (ex: prisoners, mentally disabled)
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
- Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- Patient with second primary cancer
- Extensive previous abdominal surgery
Show all 12Show fewer
- Prior radiation treatment for prostate or kidney cancer
- Patient with distant metastasis
- Complex renal vascular anatomy
- Patient with kidney cancer - stage T3 or N+ M+ **
- Horseshoe kidney**
- Previous ipsilateral kidney surgery **- specific to kidney surgery -
Trial locations and contacts
1 site in 1 country.
About this study
To determine the feasibility of representative urologic procedures as measured by the rate of conversions
- Conditions
- Prostate and Kidney Cancer
- Being tested
- da Vinci Sp Surgical System - Robotic
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Sp Surgical System - RoboticDevice
robotic assisted laparoscopic single-port system
| Study group | Role | What they receive |
|---|---|---|
| da Vinci Sp Surgical System | Experimental | da Vinci Sp Surgical System - Robotic - assisted single-port surgery Receives: Device: da Vinci Sp Surgical System - Robotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility as measured by the rate of conversions
Rate of Conversion to Open approach
Measured: Intra Operative
Secondary outcomes (5)
Perioperative surgical outcomes
Perioperative surgical outcomes length of hospital stay- From admission to discharge from the hospital for the primary procedure
Measured: From admission to discharge from the hospital for the primary procedure typically up to 7 days
Perioperative Surgical outcomes
Rate of Transfusion
Measured: Intra-operative
Perioperative Surgical Outcomes
Procedure specific wound complications , infection
Measured: 30 day, 1 year , 2 year and 3 year follow up
Post-operative - Continence
Continence measured by use of pads
Measured: 1 year, 2 year and 3 year follow up
Perioperative Surgical Outcome- potency
Potency rate administered by International Index of Erectile Function patient questionnaire
Measured: 1 , 2 and 3 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJun 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate and Kidney CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold Villers, MD, Principal investigator, Hôpital HURIEZ, CHRUJihad Kaouk, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136121
- Sponsor's protocol ID
- 001
- Status last verified
- May 2014
- First submitted
- 5 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kaouk JH, Haber GP, Autorino R, Crouzet S, Ouzzane A, Flamand V, Villers A. A novel robotic system for single-port urologic surgery: first clinical investigation. Eur Urol. 2014 Dec;66(6):1033-43. doi: 10.1016/j.eururo.2014.06.039. Epub 2014 Jul 17.
PubMed 25041850
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of Robotic Single-port System
- ClinicalTrials.gov ID
- NCT02136121
- Acronym / sponsor ID
- 001
- Conditions
- Prostate and Kidney Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 May 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.
To determine the feasibility of representative urologic procedures as measured by the rate of conversions
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| da Vinci Sp Surgical System | Experimental | Device: da Vinci Sp Surgical System - Roboticda Vinci Sp Surgical System - Robotic - assisted single-port surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prostatectomy:
- Patients age 18-75 years
- BMI <=35 kg/m2
- Confirmed localized adenocarcinoma of the prostate
- Suitable for minimally invasive prostate cancer surgery
Key exclusion criteria (12 listed)
- Untreated active infection (includes local kidney infection)
- Vulnerable population (ex: prisoners, mentally disabled)
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
- Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
- Patient with second primary cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci Sp Surgical System - Roboticrobotic assisted laparoscopic single-port system | Device | da Vinci Sp Surgical System |
Primary outcome
To determine the feasibility as measured by the rate of conversions
Time frame: Intra Operative
Rate of Conversion to Open approach
5 secondary outcomes
Perioperative surgical outcomes
Time frame: From admission to discharge from the hospital for the primary procedure typically up to 7 days
Perioperative Surgical outcomes
Time frame: Intra-operative
Perioperative Surgical Outcomes
Time frame: 30 day, 1 year , 2 year and 3 year follow up
Post-operative - Continence
Time frame: 1 year, 2 year and 3 year follow up
Perioperative Surgical Outcome- potency
Time frame: 1 , 2 and 3 year follow up
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 12 May 2014.
- Derived from this study: PubMed 25041850Kaouk JH, Haber GP, Autorino R, Crouzet S, Ouzzane A, Flamand V, Villers A. A novel robotic system for single-port urologic surgery: first clinical investigation. Eur Urol. 2014 Dec;66(6):1033-43. doi: 10.1016/j.eururo.2014.06.039. Epub 2014 Jul 17.
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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.
Arnold Villers, MD principal investigator
Hôpital HURIEZ, CHRU
Jihad Kaouk, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing da Vinci Sp Surgical System - Robotic in people with Prostate and Kidney Cancer, run by Intuitive Surgical at 1 site in France.
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 10 inclusion and 12 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 12 May 2014. 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 France. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the feasibility as measured by the rate of conversions (time frame: Intra Operative). 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 NCT02136121, which also lists 1 linked publication.
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 12 May 2014.