A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:January 22, 2019
End Date:December 2019
Contact:Andrea L DiScipio
Email:andrea.l.discipio@medtronic.com
Phone:781-491-5350

Use our guide to learn which trials are right for you!

To Confirm the Safety and Performance of the Signia™ Stapling System Using Signia™ Intelligent Loading Units With Tri-Staple™ 2.0 Intelligent Reloads in Abdominal and Thoracic Procedures.

The objectives of this prospective, two-arm, multicenter post-market study is to confirm
safety and performance through the incidence of subjects reporting serious adverse device
effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo
GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects
undergoing indicated abdominal or thoracic procedures for resection, transection and creation
of anastomosis per the IFU.

This study will evaluate the use of Signia™ Stapling System using Signia™ Intelligent Loading
Units with Tri-Staple™ 2.0 Intelligent Reloads in indicated abdominal or thoracic procedures
(e.g., resection, transection of tissue, and creation of anastomoses). Subjects who meet the
eligibility criteria will be considered for study participation at a minimum of 10 sites and
will be followed up to and including 30 days post-operative. Overall the study is estimated
to progress for up to 24 months.

Inclusion Criteria:

1. Adults (male or female) between 22 and 80 years of age inclusive at the time of the
procedure.

2. The subject must be willing and able to participate in the study procedures and to
understand and sign the informed consent.

3. The subject is scheduled to undergo an indicated primary abdominal or thoracic
procedure for resection, transection and creation of anastomosis per the IFU where the
Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0
Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate
for the procedure only Medtronic buttresses can be used during the course of the
study.

3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy,
and may include video assisted thoracic surgery (VATS) or open procedures.

3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve
gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion Criteria:

1. Subjects undergoing cardiac and vascular procedures.

2. The procedure is an emergency procedure.

3. The procedure is a revision/reoperation of a primary operation..

4. Any female subject who is pregnant. 4a. Females of child-bearing potential will be
required to undergo either a urine pregnancy test or serum pregnancy test during
Screening and confirmed on the day of operation (except for subjects who are
surgically sterile or are post-menopausal for at least two years) (USA only) and per
EU local requirements.

5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or
those without sufficient mental capacity).

6. The subject is unable or unwilling to comply with the study requirements or follow-up
schedule.

7. The subject has comorbidities which, in the clinical judgment of the Investigator,
will not be appropriate for the study or the subject has an estimated life expectancy
of less than 6 months.

8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active
and not reversed anticoagulant treatment.

9. The subject is concurrently enrolled in another investigational drug or device
research study or has been enrolled in another study within 30 days of enrollment.

10. Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications
as described in the IFU.
We found this trial at
2
sites
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Tejinder P Singh
Phone: 518-262-5018
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
?
mi
from
Albany, NY
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Harmik Soukiasian
Phone: 310-423-8762
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials