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

NCT02807376 | Completed Results

• 1 other identifier: 15-002
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Excision of Kidney

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Post-Op through 4 Week Follow-up

Study Arms (2)

Surgeon's 'standard of care' stapler

ACTIVE COMPARATOR

Surgeon's standard of care stapler

Device: Surgeon's 'standard of care' stapler

Ethicon Powered Vascular Stapler

EXPERIMENTAL

Ethicon Powered Vascular Stapler

Device: Ethicon Powered Vascular Stapler

Interventions

Surgeon's 'standard of care' stapler DEVICE

Surgeon's 'standard of care' stapler

Ethicon Powered Vascular Stapler DEVICE

Ethicon Powered Vascular Stapler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Results Point of Contact

• Title: Michael Schwiers
• Organization: Ethicon

mschwier@its.jnj.com

513-337-1172

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 21, 2016
• Study Start: July 5, 2016
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-11

Locations

US (1)