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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515811
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Brief Summary:
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.

Condition or disease Intervention/treatment
Abdominal Injury Thoracic Diseases Device: Signia™ Stapling System

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 127 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
Abdominal

Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.

Abdominal (approximately 53 subjects).

Device: Signia™ Stapling System
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Thoracic

Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads.

Thoracic (approximately 74 subjects).

Device: Signia™ Stapling System
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.




Primary Outcome Measures :
  1. The primary endpoint is the incidence of subjects reporting serious adverse device effects (ADEs) including intra- and post-operative leaks. [ Time Frame: Up to and including 30 days intra- and post-operative ]
    The primary endpoint is the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days including intra- and post-operative leaks. The causes of these leaks will be documented when available.


Secondary Outcome Measures :
  1. The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device include: staple line assessment, incidence of repeat hospital admissions for primary procedure-related complications. [ Time Frame: Up to and including 30 days intra- and post-operative ]

    The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device to include: Staple line assessment (intra-operative and post-operative).

    Incidence of repeat hospital admissions for primary procedure-related complications.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
74 Thoracic subjects arm 53 abdominal subjects arm
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515811


Contacts
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Contact: Andrea L DiScipio 781-491-5350 andrea.l.discipio@medtronic.com
Contact: Michael Pace 781-460-1554 michael.pace@medtronic.com

Locations
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United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Jenny Park    310-423-8762    Jenny.Park@cshs.org   
Principal Investigator: Harmik Soukiasian         
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Nancy Giebelhaus, RN    518-262-5018    GiebelN@amc.edu   
Principal Investigator: Tejinder P Singh         
Sponsors and Collaborators
Medtronic - MITG

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03515811     History of Changes
Other Study ID Numbers: MDT17025SIG
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Thoracic Diseases
Abdominal Injuries
Respiratory Tract Diseases
Wounds and Injuries