Clinical trial NCT03515811: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Injury
Thoracic Diseases
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 74 Thoracic subjects arm 53 abdominal subjects arm

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.

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.

Primary outcomes:
measure: The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
timeFrame: Up to and including 30 days intra- and post-operative.
measure: The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.
timeFrame: Up to and including 30 (+14) days post-procedure.
Secondary outcomes:
measure: The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.
timeFrame: Up to and including 30 (+14) days post-operative.
measure: The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.
timeFrame: Up to and including 30 (+14) days post-operative.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Cary
country: United States
facility: WakeMed Bariatric Specialists of North Carolina
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Monza
country: Italy
facility: Azienda Ospedaleria San Gerardo
city: Sevilla
country: Spain
facility: Hospital Universitario del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
Study officials:
affiliation: Medtronic
name: Kelley Kennedy
role: STUDY_DIRECTOR
References: