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

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Incidence of anastomotic leak [Срок оценки: within 30 days, +/- 14 days]

Вторичные конечные точки (7)

• Incidence of anastomotic leaks [Срок оценки: within 90 days, +/- 14 days]
• Clinical significance of anastomotic leaks [Срок оценки: within 90 days, +/- 14 days]
• Incidence of a Signia™ circular stapler and accessory components device deficiency (DD) [Срок оценки: Day 0 (day of surgery)]
• Incidence of anastomotic bleeding [Срок оценки: within 30 and 90 days, +/- 14 days]
• Incidence of device-related adverse events [Срок оценки: within 90 days, +/- 14 days]
• Length of hospital stay [Срок оценки: discharge (post-surgery up to 90 days, +/- 14 days)]
• Incidence of re-operation or surgical intervention [Срок оценки: within 90 days, +/- 14 days]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• 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
• … и ещё 1 центр

Идентификаторы

NCT: NCT07351071 · MDT24002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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