NCT07351071 · Medtronic - MITG
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
(SECURE)
What this study is about
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.
View original scientific description
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject is competent and willing to provide documented informed consent to participate in this clinical study
- Subject is intended to undergo an elective left sided colon/colorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler
- Subject is ≥ 18 years of age at time of consent Preoperative
Exclusion criteria
- Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- Subject with ASA classification ≥ IV
- Subject is pregnant (as determined by standard site practices)
- The procedure is an emergency procedure
- The procedure is a revision/reoperation for the same indication
- The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months
- Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study
- Subject will undergo multiple synchronous colon resections
- Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)
- Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure
- Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)
- Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)
- Any subject undergoing an ileal-anal pouch anastomosis surgery Intraoperative Exclusion Criteria
- Anastomosis not attempted with the Signia™ circular stapler
- Any subject for which the device is intended to be used outside the instructions for use (IFU)
Where
- New Haven, Connecticut
- Tampa, Florida
- Boston, Massachusetts
- Rochester, Minnesota
- Durham, North Carolina
- Columbus, Ohio
- Wynnewood, Pennsylvania
- Houston, Texas
- Madison, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations