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Recruiting NCT07351071

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

No phase Interventional Colorectal Anastomosis Left-sided Colon Resection Anastomotic Leak Anastomotic Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system).
Who it may be relevant to
Registry conditions: Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Device Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
    Signia™ Circular Stapling system used for the creation of an anastomosis

Primary outcome measures

  • Incidence of anastomotic leak [Time frame: within 30 days, +/- 14 days]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Yale University — New Haven
  • The University of South Florida — Tampa
  • Massachusetts General Hospital — Boston
  • Mayo Clinic — Rochester
  • Duke University — Durham
  • The Ohio State University Wexner Medical Center — Columbus
  • Lankenau Institute for Medical Research — Wynnewood
  • University of Texas Health Science Center at Houston — Houston
  • … and 1 more center

Identifiers

NCT: NCT07351071 · MDT24002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗