Magnet System Gastric Outlet Obstruction Study

Официальное название

Creation of Magnetic Compression Gastroenterostomy Using the GT Metabolic Solutions Magnet System in Adults With Gastric Outlet Obstruction (GOO): Magnet System GOO Study

Обзор

Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).

Подробное описание

The purpose of this clinical research study is to evaluate performance and safety of the GT Metabolic Magnet System for creation of a side-to-side gastroenteral anastomosis in adults. The Magnet System is a surgical tool and is intended for use in clinical procedures requiring an anastomosis. Gastroenterostomy for gastric outley obstruction (GOO) is one example of a clinical procedure requiring a gastroenteral anastomosis. Gastroenterostomy is most often created today using incisions and sutures or staples. This study explores creation of a gastroenterostomy with magnetic compression anastomosis.

Вмешательства

• Устройство Magnet System
  Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy

Первичные конечные точки

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

Критерии участия

Критерии включения

• Gastric outlet obstruction (GOO) and indicated for a gastroenterostomy, per the discretion of the treating investigator.
• If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.
• Willing and able to comply with protocol requirements and provides written informed consent to participate in the study.

Критерии исключения

• Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.
• If GOO due to malignant neoplasm:
• Baseline Eastern Cooperative Oncology Group (ECOG) > 2 and/or Karnofsky Performance score < 30
• Gastric or intestinal cancer or malignant infiltration precluding creation of a magnetic compression anastomosis (per investigator discretion)
• Coagulation disorders, on continuous or complete anticoagulation, or other conditions associated with high risk of bleeding and not correctable or manageable, precluding creation of a magnetic compression anastomosis (per investigator discretion)
• Any anomaly precluding orogastric access by endoscope and catheters, and manipulation techniques.
• Implantable pacemaker or defibrillator.
• Woman who is either pregnant or breast feeding.
• Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets.
• Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment sites.
• Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months after the procedure.
• Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures.
• Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
• Unable to comply with the follow-up schedule and assessments.
• Known allergies to the device components or contrast media.
• Currently participating in another clinical research study with an investigational drug or medical device.
• Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 90 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen.

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

Чехия · 1 центр

• General University Hospital — Prague

Идентификаторы

NCT: NCT07609511 · GTM-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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