GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

Официальное название

Compression Anastomosis Using the GT Metabolic Magnet System in Adults With Gastrointestinal Disorders (GT Metabolic Magnet System Study)

Обзор

Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.

Подробное описание

Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel obstruction, SMAS, or GOO due to their similarities (they all involve a physical impediment (e.g., compression of the intestinal lumen) and/or mechanical blockage of the GI tract).

Вмешательства

• Устройство Magnet System
  Magnetic compression anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome.

Первичные конечные точки

• Magnet Placement [Срок оценки: 1 day]
• Natural Magnet Passage [Срок оценки: 90 days]
• Anastomosis Patency [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis, without need for immediate lumen patency, and meets one of the following criteria:

• Superior mesenteric artery syndrome (SMAS); OR
• Gastric outlet obstruction (GOO); OR
• Partial small bowel obstruction.
• Meets the surgical clearance requirements as governed by the investigator's institution.
• If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.

Критерии исключения

• Other gastrointestinal or abdominal surgeries planned concurrently or within the study follow-up period (e.g., bariatric surgery such as sleeve gastrectomy).
• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the anastomosis or study procedure, including scarring and abnormal anatomy at the anastomosis sites.
• Any anomaly precluding gastrointestinal access by gastroscope / endoscope, catheters, and associated manipulation techniques for device placement.
• Any condition or disease that precludes laparoscopic surgery.
• Implantable pacemaker, defibrillator, other active and/or metallic implant that may interfere with or be adversely impacted by a temporary magnetic implant (Magnet System) and associated procedures.
• Unhealed ulcers, bleeding lesions, tumor, diseased tissue or any other lesion at or distal to the target Magnet deployment sites.
• Any need for immediate lumen patency while the anastomosis is formed.
• History of prior or current malignancy.
• Expected need for Magnetic Resonance Imaging (MRI) within the first 3 months post-procedure (or before if Magnet expulsion is confirmed radiologically).
• Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
• Pregnant, lactating, or planning pregnancy during the clinical investigation and follow up period.
• Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
• Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.

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

Канада · 1 центр

• Westmount Surgical Center — Westmount

Идентификаторы

NCT: NCT07317076 · GTM-020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗