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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-22

Study Completion Date

2020-07-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Injury Thoracic Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal

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

Abdominal (approximately 53 subjects).

Signia™ Stapling System

Intervention Type DEVICE

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).

Signia™ Stapling System

Intervention Type DEVICE

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

Interventions

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Signia™ Stapling System

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No