Renal Transplant Donor of Left KidneyNCT01925677
Robotic Single Port Donor Nephrectomy
A study testing da Vinci® Single-Site™ in people with Renal Transplant Donor of Left Kidney and Donor Nephrectomy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Donor of Left Kidney, Donor Nephrectomy, Robotic Surgery
- What is being tested?
- da Vinci® Single-Site™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be approved by the Living Donor Center.
- Patient must have compatible blood type with the recipient.
- Patient must have body mass index less than 35.
- Patient must have appropriate anatomy for left kidney donation.
Who cannot join
- Any patient receiving anticoagulant drugs such as Coumadin or warfin
- Any patient suffering from an active urinary tract infections
- Any patients suffering from cancer.
- Any patients suffering from diabetes.
- Any patients suffering from kidney disease.
- Any patients suffering from heart disease.
Show all 10Show fewer
- Any patients suffering from liver disease.
- Any patients suffering from HIV or hepatitis
- Any patients suffering from previous major abdominal surgery.
- Any patients suffering from more than two left renal arteries.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
Read the detailed description
Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach. The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery. After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices.
- Being tested
- da Vinci® Single-Site™
- Keywords
- Transplant, donor, nephrectomy, robotic, laparoscopy, single-port
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci® Single-Site™Device
Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
| Study group | Role | What they receive |
|---|---|---|
| da Vinci® Single-Site™ | Experimental | Robotic-assisted single-incision laparoscopic nephrectomy. Receives: Device: da Vinci® Single-Site™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Completion of the Surgical Procedure
The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation.
Measured: during operation
Secondary outcomes (3)
Operative Times
Operative times will closely be measured
Measured: during operation
Blood Loss
Blood loss of patients will be closely monitored and recorded.
Measured: during operation
The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.
A surgeon ergonomics questionnaire will be given to surgeons after performing both robotic assisted and standard laparoscopic single port donor nephrectomies. The results from both of these surveys will then be compared. These are qualitative and were not analyzed for statistical trends.
Measured: intra-operative experience collected within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJan 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Donor of Left KidneyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Barth, University of Maryland, Baltimore
- Investigators
- Rolf N Barth, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925677
- Sponsor's protocol ID
- HP-00055955
- Status last verified
- Nov 2019
- First submitted
- 6 Aug 2013
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barth RN, Phelan MW, Goldschen L, Munivenkatappa RB, Jacobs SC, Bartlett ST, Philosophe B. Single-port donor nephrectomy provides improved patient satisfaction and equivalent outcomes. Ann Surg. 2013 Mar;257(3):527-33. doi: 10.1097/SLA.0b013e318262ddd6.
PubMed 22968070
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
- ClinicalTrials.gov ID
- NCT01925677
- Acronym / sponsor ID
- HP-00055955
- Keywords
- Transplant, donor, nephrectomy, robotic, laparoscopy, single-port
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
Detailed description
Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach. The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery. After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| da Vinci® Single-Site™ | Experimental | Device: da Vinci® Single-Site™Robotic-assisted single-incision laparoscopic nephrectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be approved by the Living Donor Center.
- Patient must have compatible blood type with the recipient.
- Patient must have body mass index less than 35.
- Patient must have appropriate anatomy for left kidney donation.
Key exclusion criteria (10 listed)
- Any patient receiving anticoagulant drugs such as Coumadin or warfin
- Any patient suffering from an active urinary tract infections
- Any patients suffering from cancer.
- Any patients suffering from diabetes.
- Any patients suffering from kidney disease.
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® Single-Site™Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System. | Device | da Vinci® Single-Site™ |
Primary outcome
Successful Completion of the Surgical Procedure
Time frame: during operation
The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation.
3 secondary outcomes
Operative Times
Time frame: during operation
Blood Loss
Time frame: during operation
The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.
Time frame: intra-operative experience collected within 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22968070Barth RN, Phelan MW, Goldschen L, Munivenkatappa RB, Jacobs SC, Bartlett ST, Philosophe B. Single-port donor nephrectomy provides improved patient satisfaction and equivalent outcomes. Ann Surg. 2013 Mar;257(3):527-33. doi: 10.1097/SLA.0b013e318262ddd6.
- 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.
Rolf N Barth, M.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci® Single-Site™ in people with Renal Transplant Donor of Left Kidney and Donor Nephrectomy, run by University of Maryland, Baltimore 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 4 inclusion and 10 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 20 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Completion of the Surgical Procedure (time frame: during operation). 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 NCT01925677, 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 20 Nov 2019.