Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Purpose
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.
Conditions
- Colorectal Anastomosis
- Left-sided Colon Resection
- Anastomotic Leak
- Anastomotic Complication
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Postoperative Complications
- Anastomotic Leaks
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Left sided colon/colorectal procedure with creation of an anastomosis |
single arm study, no control arm |
|
Recruiting Locations
University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Medtronic - MITG
Detailed Description
The primary objective of this study is to evaluate the safety and performance of the Signia™ circular stapler, for the creation of anastomoses assessed by the incidence of anastomotic leak within 30 days following use in subjects undergoing left sided colon, sigmoid, or rectal resections. The secondary objectives of this study are to assess safety and performance outcomes within 90 days following the use of the Signia™ circular stapler in subjects undergoing left sided colon, sigmoid, or rectal resections.