Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left sided colon/colorectal procedure with creation of an anastomosis | Experimental | single arm study, no control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) | Device | Signia™ Circular Stapling system used for the creation of an anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anastomotic leak | Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis. | within 30 days, +/- 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anastomotic leaks | Incidence of anastomotic leak following the use of the Signia™ circular stapler used in subjects undergoing left sided colon, sigmoid, or rectal resections. Diagnosis will be confirmed postoperatively by computed tomography (CT) imaging (with or without a contrast agent), or postoperatively via direct verification during re-operation. Anastomotic leakage confirmed to have occurred at a staple line other than the colon/colorectal anastomosis created with the Signia™ circular stapler will not impact the primary endpoint analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon satisfaction | Surgeon satisfaction via a questionnaire | Day 0 (day of surgery) |
| Incidence of serious device-related adverse events | serious device-related adverse events related to Signia™ circular stapler and accessory components. A serious adverse event is defined as an "Adverse event that led to any of the following:
|
Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeshareg Yismaw | Contact | +7635050079 | yeshareg.g.yismaw@medtronic.com | |
| Study Mailbox | Contact | rs.securestudy@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Katharine Louise Jackson, MD, FACS, MBBS, MA | Duke Raleigh Hospital | Principal Investigator |
| John Monson, MD, FACS | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States | |
| The University of South Florida |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| within 90 days, +/- 14 days |
| Clinical significance of anastomotic leaks | Anastomotic leaks graded according to International Study Group of Rectal Cancer (ISGRC): Grade A: Anastomotic leakage results in no change in patients' management. Grade B: Leakage requires active therapeutic intervention but is manageable without re-laparotomy/operative intervention*. Grade C: Anastomotic leakage requires re-laparotomy/operative intervention*. *Operative intervention was added to the ISGRC definition for the purpose of this study. | within 90 days, +/- 14 days |
| Incidence of a Signia™ circular stapler and accessory components device deficiency (DD) | Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance. | Day 0 (day of surgery) |
| Incidence of anastomotic bleeding | bleeding at the anastomotic site that requires endoscopic or surgical intervention | within 30 and 90 days, +/- 14 days |
| Incidence of device-related adverse events | Adverse events related to Signia™ circular stapler and accessory components. An adverse event is defined as "Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated." | within 90 days, +/- 14 days |
| Length of hospital stay | Length of hospital stay for the index procedure (from admission to discharge) after the Signia™ circular stapler was used in subjects undergoing left sided colon, sigmoid, or rectal resections | discharge (post-surgery up to 90 days, +/- 14 days) |
| Incidence of re-operation or surgical intervention | Incidence of re-operation or surgical intervention due to an adverse event related to the Signia™ circular stapler or accessory components | within 90 days, +/- 14 days |
| within 90 days, +/- 14 days |
| Clavien-Dindo classification of surgical complications | Clavien-Dindo classification of postoperative device related adverse events and serious device related adverse events. | within 90 days, +/- 14 days |
| Readmission to hospital | Readmission to hospital for study index procedure-related complications | within 30 and 90 day, +/- 14 days |
| Recruiting |
| Tampa |
| Florida |
| 33620 |
| United States |
| Massachusetts General Hospital | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic | Not yet recruiting | Rochester | Minnesota | 55902 | United States |
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| Lankenau Institute for Medical Research | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
| University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| SSM Health St. Mary's Hospital - Madison | Not yet recruiting | Madison | Wisconsin | 53715 | United States |
| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided