A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
Public ClinicalTrials.gov record NCT03515811. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03515811
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 136 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 22, 2019 (Actual)
- Primary completion
- Jul 13, 2020 (Actual)
- Completion
- Jul 13, 2020 (Actual)
- Last update posted
- May 10, 2024
2019 – 2020
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| WakeMed Bariatric Specialists of North Carolina | Cary | North Carolina | 27518 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke Regional Hospital | Durham | North Carolina | 27710 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03515811, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 10, 2024 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03515811 live on ClinicalTrials.gov.