Colorectal AnastomosisSECURENCT07351071
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
A study testing Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) in people with Colorectal Anastomosis and Left-sided Colon Resection, run by Medtronic - MITG at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak
- What is being tested?
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Preoperative 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)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Mailbox contact
10 sites in 1 country
United States10 sites, 9 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Recruiting
Duke University
Durham, North Carolina, 27705
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
SSM Health St. Mary's Hospital - Madison
Madison, Wisconsin, 53715
- Not yet recruiting
Wellstar Hospital
Marietta, Georgia, 30060
- Recruiting
Yale University
New Haven, Connecticut, 06520
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55902
- Active, not recruiting
The University of South Florida
Tampa, Florida, 33620
- Recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication, Digestive System Diseases, Gastrointestinal Diseases
- Being tested
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Keywords
- Colorectal Anastomosis, Left-sided Colon Resection, Circular stapler, Anastomotic Leak, Rectal cancer, Low anterior resection, Powered stapler
- Medical subject headings
- Anastomotic Leak, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)Device
Signia™ Circular Stapling system used for the creation of an anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Left sided colon/colorectal procedure with creation of an anastomosis | Experimental | single arm study, no control arm Receives: Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days, +/- 14 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Day 0 (day of surgery)
Incidence of anastomotic bleeding
bleeding at the anastomotic site that requires endoscopic or surgical intervention
Measured: 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."
Measured: 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
Measured: 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
Measured: within 90 days, +/- 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Dec 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AnastomosisStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katharine Louise Jackson, MD, FACS, MBBS, MA, Principal investigator, Duke Raleigh HospitalJohn Monson, MD, FACS, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351071
- Sponsor's protocol ID
- MDT24002
- Acronym
- SECURE
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07351071
- Acronym / sponsor ID
- SECURE / MDT24002
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication, Digestive System Diseases, Gastrointestinal Diseases
- Keywords
- Colorectal Anastomosis, Left-sided Colon Resection, Circular stapler, Anastomotic Leak, Rectal cancer, Low anterior resection, Powered stapler
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left sided colon/colorectal procedure with creation of an anastomosis | Experimental | Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)single arm study, no control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)Signia™ Circular Stapling system used for the creation of an anastomosis | Device | Left sided colon/colorectal procedure with creation of an anastomosis |
Primary outcome
Incidence of anastomotic leak
Time frame: within 30 days, +/- 14 days
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.
7 secondary outcomes
Incidence of anastomotic leaks
Time frame: within 90 days, +/- 14 days
Clinical significance of anastomotic leaks
Time frame: within 90 days, +/- 14 days
Incidence of a Signia™ circular stapler and accessory components device deficiency (DD)
Time frame: Day 0 (day of surgery)
Incidence of anastomotic bleeding
Time frame: within 30 and 90 days, +/- 14 days
Incidence of device-related adverse events
Time frame: within 90 days, +/- 14 days
Length of hospital stay
Time frame: discharge (post-surgery up to 90 days, +/- 14 days)
Incidence of re-operation or surgical intervention
Time frame: within 90 days, +/- 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Anastomosis
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Enrolling by invitation
Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
Low Rectal Cancer, Rectal Neoplasms
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Mailbox contact
Katharine Louise Jackson, MD, FACS, MBBS, MA principal investigator
Duke Raleigh Hospital
John Monson, MD, FACS principal investigator
Northwell Health
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) in people with Colorectal Anastomosis and Left-sided Colon Resection, run by Medtronic - MITG at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeshareg Yismaw (+7635050079, yeshareg.g.yismaw@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anastomotic leak (time frame: within 30 days, +/- 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.