Excision of KidneyNCT02807376

An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

A study testing Ethicon Powered Vascular Stapler in people with Excision of Kidney, run by Ethicon Endo-Surgery at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Excision of Kidney
What is being tested?: Ethicon Powered Vascular Stapler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2016to 23 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
American Society of Anesthesiologists (ASA) score < 3;
No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed);
Willing to give consent and comply with study-related evaluation and treatment schedule; and
At least 18 years of age

Who cannot join

Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
Pregnancy;
Physical or psychological condition which would impair study participation; or
The subject is judged unsuitable for study participation by the Investigator for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

Conditions: Excision of Kidney
Being tested: Surgeon's 'standard of care' stapler, Ethicon Powered Vascular Stapler

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surgeon's 'standard of care' staplerDevice
Ethicon Powered Vascular StaplerDevice

Study groups in NCT02807376
Study group	Role	What they receive
Surgeon's 'standard of care' stapler	Active comparator	Surgeon's standard of care stapler Receives: Device: Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler	Experimental	Ethicon Powered Vascular Stapler Receives: Device: Ethicon Powered Vascular Stapler

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Measured: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours

Secondary outcomes (1)

Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding
Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of SOC or PVS:
- Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to Renal Artery and Renal Vein transection).
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Measured: Post-Op through 4 Week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201623 Aug 2017

First posted21 Jun 2016 (estimated)
Study start5 Jul 2016
Primary completion23 Aug 2017
Study completion23 Aug 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.
Other trials for Excision of 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02807376
Sponsor's protocol ID: 15-002
Status last verified: Nov 2018
First submitted: 14 Jun 2016
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Excision of Kidney trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
ClinicalTrials.gov ID: NCT02807376
Acronym / sponsor ID: 15-002
Conditions: Excision of Kidney
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: 5 Jul 2016 (actual)
Primary completion: 23 Aug 2017 (actual)
Study completion: 23 Aug 2017 (actual)
First posted: 21 Jun 2016 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Surgeon's 'standard of care' stapler	Active comparator	Device: Surgeon's 'standard of care' staplerSurgeon's standard of care stapler
Ethicon Powered Vascular Stapler	Experimental	Device: Ethicon Powered Vascular StaplerEthicon Powered Vascular Stapler

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
American Society of Anesthesiologists (ASA) score < 3;
No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed);
Willing to give consent and comply with study-related evaluation and treatment schedule; and

Key exclusion criteria (4 listed)

Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
Pregnancy;
Physical or psychological condition which would impair study participation; or
The subject is judged unsuitable for study participation by the Investigator for any other reason.

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
Surgeon's 'standard of care' stapler	Device	Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler	Device	Ethicon Powered Vascular Stapler

Primary outcome

Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
Time frame: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).

1 secondary outcome

Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding
Time frame: Post-Op through 4 Week Follow-up

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	139	136
Powered Vascular Stapler	131	130

Primary outcome: Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions

Time frame: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours. Number (95% Confidence Interval). Unit: proportion of transected vessels

Measure	Standard of Care n = 139	Powered Vascular Stapler n = 131
Value	0.1359 (0.0977 to 0.1741)	0.1836 (0.1402 to 0.2271)

Population analysed: All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 Weeks Post Procedure. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	21 of 139 (15.1%)	26 of 139 (18.7%)	0 of 139
Powered Vascular Stapler	14 of 131 (10.7%)	33 of 131 (25.2%)	0 of 131

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 1
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
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RecruitingPhase 2
Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery
Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Recruiting
A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
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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 Ethicon Powered Vascular Stapler in people with Excision of Kidney, run by Ethicon Endo-Surgery 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 4 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 19 Dec 2018. 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 19 Dec 2018). 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?

Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions (time frame: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours). 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 NCT02807376.

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 19 Dec 2018.