An interventional study of Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system) in Colorectal Anastomosis, Left-sided Colon Resection and Anastomotic Leak, sponsored by Medtronic - MITG. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Medtronic - MITG (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 137 is close to the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Medtronic - MITG is the lead sponsor of 179 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single arm study, no control arm
Device: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
Signia™ Circular Stapling system used for the creation of an anastomosis
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.
Time frame: within 30 days, +/- 14 days
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 (day of surgery)
Incidence of anastomotic bleeding
bleeding at the anastomotic site that requires endoscopic or surgical intervention
Time frame: 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."
Time frame: 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
Time frame: 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
Time frame: within 90 days, +/- 14 days
Surgeon satisfaction
Surgeon satisfaction via a questionnaire
Time frame: 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: 1. Death, 2. Serious deterioration in the health of the subject, users or other persons as defined by one or more of the following: 1. a life-threatening illness or injury, or 2. a permanent impairment of a body structure or a body function including chronic diseases, or 3. in-patient or prolonged hospitalization, or 4. medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function, or 3. foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment.
Time frame: 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.
Time frame: within 90 days, +/- 14 days
Readmission to hospital
Readmission to hospital for study index procedure-related complications
Time frame: within 30 and 90 day, +/- 14 days
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Apr 2027, 16 months after the start.
Of 65 interventional studies with no phase under Anastomotic Leak, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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