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

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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

Tracking Information
First Submitted Date April 23, 2018
First Posted Date May 4, 2018
Last Update Posted Date January 25, 2019
Actual Study Start Date January 22, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03515811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 23, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
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.
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.
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 74 Thoracic subjects arm 53 abdominal subjects arm
Condition
  • Abdominal Injury
  • Thoracic Diseases
Intervention Device: Signia™ Stapling System
Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
Study Groups/Cohorts
  • Abdominal

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

    Abdominal (approximately 53 subjects).

    Intervention: Device: Signia™ Stapling System
  • Thoracic

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

    Thoracic (approximately 74 subjects).

    Intervention: Device: Signia™ Stapling System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2018)
127
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andrea L DiScipio 781-491-5350 andrea.l.discipio@medtronic.com
Contact: Michael Pace 781-460-1554 michael.pace@medtronic.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03515811
Other Study ID Numbers MDT17025SIG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Medtronic - MITG
Study Sponsor Medtronic - MITG
Collaborators Not Provided
Investigators Not Provided
PRS Account Medtronic - MITG
Verification Date January 2019