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Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how safe the Signia circular stapler is and how well it works after it has entered the market. It is for adults having planned surgery to remove part of the left side of the colon or rectum and join the bowel ends.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you agree to join.
  • You can understand the study and are willing to give written consent.
  • You plan to have non-emergency surgery on the left side of your colon or rectum, with the Signia circular stapler used to join the bowel ends.

Who can't join

  • You cannot or will not follow study rules or attend follow-up visits, or you take part in another drug or device study that could affect the results.
  • You have an ASA rating of IV or higher (very severe illness), another health problem the study doctor considers unsuitable, or an expected lifespan of less than 6 months.
  • You are pregnant, need emergency surgery, or are having repeat surgery for the same condition.
  • You will have several parts of your colon removed at the same time, or surgery to make a pouch from the small bowel and join it to the anus.
  • You have a bleeding disorder or take blood thinners whose effects have not been reversed. Blood thinners given to prevent clots as part of surgery are allowed.
  • You received chemotherapy or biologic medicines within 6 weeks before surgery.
  • You used corticosteroids or medicines that weaken the immune system for more than 3 months during the year before surgery.
  • The surgeon does not try to join the bowel ends with the Signia circular stapler, or plans to use it outside its instructions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Preoperative Inclusion Criteria: 1. Subject is competent and willing to provide documented informed consent to participate in this clinical study 2. 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 3. Subject is ≥ 18 years of age at time of consent Preoperative Exclusion Criteria: 1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule 2. Subject with ASA classification ≥ IV 3. Subject is pregnant (as determined by standard site practices) 4. The procedure is an emergency procedure 5. The procedure is a revision/reoperation for the same indication 6. 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 7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study 8. Subject will undergo multiple synchronous colon resections 9. 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) 10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure 11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure) 12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure) 13. Any subject undergoing an ileal-anal pouch anastomosis surgery Intraoperative Exclusion Criteria 1. Anastomosis not attempted with the Signia™ circular stapler 2. Any subject for which the device is intended to be used outside the instructions for use (IFU)

Study sites (10)

CT

FL

GA

MA

MN

NC

OH

PA

TX

WI