Renal TumorsNCT01104389
Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging
A study testing Fluorescence imaging in people with Renal Tumors, run by Intuitive Surgical at 1 site in United States.
Trial summary
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Tumors
- What is being tested?
- Fluorescence imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2010
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18 to 80 years.
- Urine pregnancy test negative for women of childbearing potential prior to surgery
- Subject is able to comply with the study procedures
- A CT or MRI preoperative assessment of renal cortical tumor
- The renal tumor must be stage T1a-b - T2
- Written informed consent.
Who cannot join
- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin >1.5 X normal and/or SGOT >2X normal
- Subject has uremia, serum creatinine >2.0 mg/dl.
- Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Subject is pregnant or lactating
- Subjects actively participating in another drug, biologic and/or device protocol
- The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.
- Conditions
- Renal Tumors
- Being tested
- Fluorescence imaging
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence imagingDevice
Intraoperatively acquire fluorescence images of renal tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
The feasibility of using the fluorescence imaging on the da Vinci Surgical System to detect renal cortical tumors will be measured by the rate of good or excellent images achieved intraoperatively.
Measured: Intraoperatively
Secondary outcomes (1)
Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.
Measured: up to 3 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010 (estimated)
Why it stopped: Study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorsStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104389
- Sponsor's protocol ID
- ISI-FHU-2010-01
- Status last verified
- Aug 2015
- First submitted
- 7 Apr 2010
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors
- ClinicalTrials.gov ID
- NCT01104389
- Acronym / sponsor ID
- ISI-FHU-2010-01
- Conditions
- Renal Tumors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2010 (estimated)
- First posted
- 15 Apr 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.
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages of 18 to 80 years.
- Urine pregnancy test negative for women of childbearing potential prior to surgery
- Subject is able to comply with the study procedures
- A CT or MRI preoperative assessment of renal cortical tumor
- The renal tumor must be stage T1a-b - T2
Key exclusion criteria (8 listed)
- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin >1.5 X normal and/or SGOT >2X normal
- Subject has uremia, serum creatinine >2.0 mg/dl.
- Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
- Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
- Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
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 |
|---|---|---|
| Fluorescence imagingIntraoperatively acquire fluorescence images of renal tumors | Device | – |
Primary outcome
The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
Time frame: Intraoperatively
The feasibility of using the fluorescence imaging on the da Vinci Surgical System to detect renal cortical tumors will be measured by the rate of good or excellent images achieved intraoperatively.
1 secondary outcome
Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.
Time frame: up to 3 weeks postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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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?
A study testing Fluorescence imaging in people with Renal Tumors, run by Intuitive Surgical 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Aug 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging. (time frame: Intraoperatively). 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 26 Aug 2015.