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

Medtronic

Status: Enrolling

Conditions: Postoperative Complications; Colorectal Anastomosis; Gastrointestinal Diseases; Intestinal Diseases; Anastomotic Complication; Left-sided Colon Resection; Rectal Diseases; Digestive System Diseases; Colonic Diseases; Anastomotic Leaks; Anastomotic Leak

Treatments: Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07351071

MDT24002

Details and patient eligibility

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.

Full 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.

Enrollment: 137 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Left sided colon/colorectal procedure with creation of an anastomosis

Experimental group

Description:

single arm study, no control arm

Treatment:

Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)