Идёт набор NCT07431723

Creation of Compression Anastomosis Using the GT Metabolic Magnet System

Без фазы С лечением Anastomosis, Functional Colorectal

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Magnet System.
Кому может быть актуально: Состояния в реестре: Anastomosis, Functional, Colorectal. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Чили, Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)

Обзор

Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.

Подробное описание

The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).

Вмешательства

Устройство Magnet System
Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.

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 colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy
Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.

Критерии исключения

High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5).
Severe Sarcopenia as determined by the investigator.
Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites.
Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques.
Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures.
Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System).
Psychiatric disorder, except well-controlled depression with medication for > 6 months.
Pregnant, lactating, or planning pregnancy during the clinical investigation.
Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant 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 site.
Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
Any stroke/Transient Ischemic Attack (TIA) ≤ 6 months prior to consent.
Requires chronic anticoagulation therapy (except aspirin).
Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
Current tobacco / nicotine product usage or recent product cessation ≤ 3 months prior to informed consent.
Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
Participants with comorbidities that are likely to result in a life expectancy ≤ 12 months.
Currently participating in an investigational drug or another device study that has not reached its primary endpoint
Presence of other anatomic or comorbid conditions, or other 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, or impact the scientific soundness of the clinical investigation results.