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New treatment option for Colorectal Anastomosis
Official title Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
ClinicalTrials.gov ID: NCT07351071
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Preoperative
- 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...
- Subject is ≥ 18 years of age at time of consent Preoperative
You likely can't join if
- 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...
See the full eligibility criteria
- Preoperative
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Wynnewood, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; Durham, North Carolina, United States; Columbus, Ohio, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.